<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03827135</url>
  </required_header>
  <id_info>
    <org_study_id>RiphahIU Aisha Razzaq</org_study_id>
    <nct_id>NCT03827135</nct_id>
  </id_info>
  <brief_title>Cyriax Manipulation in Cervical Discogenic Pain</brief_title>
  <official_title>Effects of Cyriax Manipulation in Cervical Discogenic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riphah International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Riphah International University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this research is to find and compare the effect of traditional physical therapy&#xD;
      and Cyriax manipulation on pain, range of motion and disability in patients with cervical&#xD;
      discogenic pain. Randomized controlled trials done at Benazir Bhutto hospital, Rawalpindi .&#xD;
      The sample size was 40. The subjects were divided in two groups, 20 subjects in traditional&#xD;
      physical therapy group and 20 in Cyriax manipulation group. Study duration was of 6 months.&#xD;
      Sampling technique applied was purposive non probability sampling technique. Only 25-45 years&#xD;
      individual with cervical discogenic pain were included. Tools used in the study are Numeric&#xD;
      pain rating scale (NPRS) and neck disablity index (NDI). Data was be analyzed through SPSS&#xD;
      21.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cervical disc displacement is a significant cause of neck and arm pain and disability in&#xD;
      majority of individuals. It causes a great burden on physical, social and emotional quality&#xD;
      of life of patients. The cervical disc herniation is characterized by prolapsed nucleus&#xD;
      pulposus material through the annulus into the spinal canal. The local mechanical or chemical&#xD;
      irritation of neural structures typically leads to symptoms of radiculopathy, head and neck&#xD;
      pain or myelopathy. The disc bulge may be postero-central to compress the dura matter,&#xD;
      causing multi segmental pain and affect the scapular area. It can also be postero-lateral&#xD;
      causing the root signs, that have dermatomal behavior and affect the upper limb in specific&#xD;
      pattern. Postero-central bulge can also shift to postero-lateral with symptoms shifting from&#xD;
      centralization to radiculopathy.&#xD;
&#xD;
      The State of U.S. Health: Burden of Diseases, Injuries and Risk Factors describes cervical&#xD;
      pain among 5 most contributing factor in causing years lived in disability. the ratio&#xD;
      tremendously increases after 40 years. Studies describing impact of chronic neck pain on&#xD;
      general health care reveals 14% of patients reports grade II to grade IV neck pain with high&#xD;
      pain intensity and disability.&#xD;
&#xD;
      Disc displacement disorders are included among the mechanical causes of neck pain.&#xD;
      Symptomatic disc displacements can occur at any age but have different clinical features&#xD;
      depending on the age group. In young adults nucleus pulposus can involve which is rare in old&#xD;
      age. Diagnoses can be established on clinical findings along with patient's history and the&#xD;
      functional examination. Disc displacement can occur in postero-central and Postero- lateral&#xD;
      displacement. Movement of the disc posteriorly causes stress on the posterior longitudinal&#xD;
      ligament and also on the anterior part of the Dura mater. As a result of this the pain&#xD;
      travels in more than one segment with dural reference. Pain occurs in trapezius and scapular&#xD;
      area. This typical poster central displacement causes the pain symptoms centrally and&#xD;
      bilaterally. Poster lateral movement of disc tissue inserts force on the nerve root, which&#xD;
      causes a Segmental pain or root pain and Segmental paraesthesia. Disc displacement may be&#xD;
      primary or secondary. Secondary poster lateral displacement is more common type of&#xD;
      displacement. Patient previously having pain in different segments like neck, trapezius and&#xD;
      scapular region now feels pain in the upper limb area. It occurs due to the lateral shifting&#xD;
      of disc tissues.&#xD;
&#xD;
      The goal of treatment in discogenic problems is to stop the conflict between the displaced&#xD;
      disc material and affecting sensitive structure. Disc fragment may affect the Dura matter,&#xD;
      nerve roots and intervertebral joints. Manipulations and traction brings back the disc&#xD;
      material to its place. The choice depends on the displacement. Nuclear displacements are&#xD;
      treated by traction while annular ones are by manipulations. Injection usually is done to&#xD;
      help pain less spontaneous recovery. If there is too much postero-central displacement that&#xD;
      it compresses the spinal cord then surgery usually is done.&#xD;
&#xD;
      Physiotherapy Treatment protocol for cervical discogenic pain include muscle strengthening&#xD;
      and to relieve stress on muscles. Cyriax manipulation is a systematic technique of&#xD;
      manipulation for the disc prolapse. this study hypothesize that there is a difference between&#xD;
      the effects of traditional physical therapy and cyriax manipulation for the discogenic&#xD;
      problems. The objecvtive of this study is to find the effects of cyriax manipulation and to&#xD;
      compare it with traditional physical therapy treatment in patients with cervical discogenic&#xD;
      pain.&#xD;
&#xD;
      Literature review A systematic and evidence based search of relevant literature was performed&#xD;
      by utilizing PubMed and Google Scholar as search engines. Search term for the initial&#xD;
      literature review was discogenic pain, prevalence of neck pain, financial burden of&#xD;
      discogenic pain, causes of neck pain, pathophysiology of discogenic pain, treatment options&#xD;
      for discogenic pain, manipulation, cyriax manipulation, short term effects of manipulation.&#xD;
      The search was limited to papers in English preferably published since 2000 with full text&#xD;
      available. Different studies were available regarding cervical manipulation and its effects&#xD;
      but limited data was available regarding cyriax manipulation in recent years.&#xD;
&#xD;
      In 2004, previously concluded 33 high quality RCTs in a Cochrane review on mobilization and&#xD;
      manipulation of mechanical neck pain. There was strong evidence that mobilization or&#xD;
      manipulations when combined with exercises are beneficial for acute or chronic neck pain with&#xD;
      or without headache. 3 -11 sessions were compared against placebo.&#xD;
&#xD;
      In literature June 2004, worked to find best evidence in a systematic review on efficacy of&#xD;
      spinal manipulation and mobilization for low back pain and neck pain. They showed that there&#xD;
      is moderate evidence that spinal manipulative therapy for chronic neck pain is superior when&#xD;
      compared to physical therapy and family physician care.&#xD;
&#xD;
      Another randomized controlled trial to correlate the results of manual therapy,&#xD;
      physiotherapy, general practitioner care, placebo in treatment of persistent neck and back&#xD;
      pain. They took the patients well defined in sub-groups. Physiotherapy included exercises,&#xD;
      massage and modalities (heat, ultra-sound, short-wave diathermy). Manual therapy included&#xD;
      spine mobilization and manipulation. General practitioner provided analgesics, posture&#xD;
      correction, home exercises and bed rest. Placebo consisted of detuned shortwave diathermy and&#xD;
      ultra-sound for 10 mines.).Changes in severity of chief complain and functional limitation&#xD;
      was main outcome measured by blinded research assistant. Results shows that manual therapy is&#xD;
      significantly better than other sub-groups in chronic conditions younger than 40 years of&#xD;
      age.&#xD;
&#xD;
      In 2015, in a Cochrane systematic review on mobilization and manipulation on neck pain showed&#xD;
      immediate effects of a single manipulation on sub-acute to chronic neck pain. Multiple&#xD;
      sessions of cervical manipulations on acute and chronic neck pain produce immediate and long&#xD;
      term effects on the pain, function and quality of life.&#xD;
&#xD;
      Howe et al suggested that Manipulation produced a significant immediate improvement in&#xD;
      symptoms in those with pain or stiffness in the neck, and pain/paraesthesia in the shoulder,&#xD;
      and a nearly significant improvement in those with pain/paraesthesia in the arm/hand.&#xD;
&#xD;
      Study on the non-surgical treatment of cervical radiculopathy suggest manipulation to be very&#xD;
      effective and safe in reducing pain, hypo-mobility and disability.&#xD;
&#xD;
      Randomized clinical trial suggest in their current randomized clinical trial that cervical&#xD;
      and thoracic thrust manipulation induce similar changes in Pressure Pain Threshold,(PPT) neck&#xD;
      pain intensity, and CROM in individuals with bilateral chronic mechanical neck pain.&#xD;
&#xD;
      The combination of manual therapy and manipulation provide better results than manual therapy&#xD;
      alone.&#xD;
&#xD;
      Compared intensive training, physiotherapy and manipulation for patients with chronic neck&#xD;
      pain after 6 months and 1 year follow up. They found that there was no significant difference&#xD;
      between the three treatments. They suggested that as it is not clear whether it is the result&#xD;
      of treatment or effect of time. Future studies are necessary to find out the exact treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 20, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neck disability index</measure>
    <time_frame>4th Day</time_frame>
    <description>Changes from base line Northwick disability index was developed first in Northwick Park hospital, England. It was designed to measure the neck pain and disability over time. It consists of 10, five parts sections. At the end, score is calculated by dividing the obtained score by total (50) multiplied by 100. As the driving section was missing in all the female patients, total score was considered as 45 instead of 50.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NPRS</measure>
    <time_frame>4th Day</time_frame>
    <description>Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ROM Cervical Spine ( Flexion)</measure>
    <time_frame>4th Day</time_frame>
    <description>Changes from the Baseline ROM range of Motion of Cervical spine flexion was taken with the Help of Goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ROM Cervical Spine ( extension)</measure>
    <time_frame>4th Day</time_frame>
    <description>Changes from the Baseline ROM range of Motion of Cervical spine extension was taken with the Help of Goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ROM Cervical Spine ( Right side flexion)</measure>
    <time_frame>4th Day</time_frame>
    <description>Changes from the Baseline ROM range of Motion of Cervical spine right side flexion was taken with the Help of Goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ROM Cervical Spine ( left side Flexion)</measure>
    <time_frame>4th Day</time_frame>
    <description>Changes from the Baseline ROM range of Motion of Cervical spine left side flexion was taken with the Help of Goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ROM Cervical Spine ( right rotation)</measure>
    <time_frame>4th Day</time_frame>
    <description>Changes from the Baseline ROM range of Motion of Cervical spine right rotation was taken with the Help of Goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ROM Cervical Spine ( left rotation)</measure>
    <time_frame>4th Day</time_frame>
    <description>Changes from the Baseline ROM range of Motion of Cervical spine left rotation was taken with the Help of Goniometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cervical Discogenic Pain (Disorder)</condition>
  <arm_group>
    <arm_group_label>Traditional physical therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cervical isometrics and Muscle Stretching</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cyriax manipulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group was given cyriax manipulation protocol along with the cervical isometrics and muscle stretching.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional physical therapy</intervention_name>
    <description>Cervical isometrics 10 repetitions×1 set, 4 days/week and targeted muscle strechings (trapezius, scalenes and sternocleidomastoid) 10 repetitions×1 set, 4 days/week.&#xD;
Total of 4 sessions were given each consisting of 40 mins.</description>
    <arm_group_label>Traditional physical therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cyriax manipulation</intervention_name>
    <description>Experimental group was given cyriax manipulation protocol along with the cervical isometrics and muscle strechings.&#xD;
Traction with rotation was not given in cases of bilateral arm pain. cervical isometrics 10 repetitions×1 set, 4 days/week and targeted muscle strechings (trapezius, scalenes and sternocleidomastoid) 10 repetitions×1 set, 4 days/week.&#xD;
Total of 4 sessions were given each consisting of 40 mins.</description>
    <arm_group_label>Cyriax manipulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed and confirmed cases of cervical disco genic pain by Weiner's criteria and&#xD;
             Cyriax clinical assessment,&#xD;
&#xD;
          -  Discogenic cases with pain either in cervico-scapular area, radiating to arm without&#xD;
             any neurological symptoms were the main objects of study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients have vertebrobasilar insufficiency (tested by VBI tests),&#xD;
&#xD;
          -  Altanto axial instability (tested by sharp purser test),&#xD;
&#xD;
          -  Osteoporosis, Rheumatoid arthritis,&#xD;
&#xD;
          -  Neuropathies,&#xD;
&#xD;
          -  Recent surgeries and neuropathies were excluded from study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdul Ghafoor Sajjad, PHD*</last_name>
    <role>Principal Investigator</role>
    <affiliation>Riphah International University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Riphah International University</name>
      <address>
        <city>Islamabad</city>
        <state>Federal</state>
        <zip>44000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>Risbud MV, Shapiro IM. Role of cytokines in intervertebral disc degeneration: pain and disc content. Nat Rev Rheumatol. 2014 Jan;10(1):44-56. doi: 10.1038/nrrheum.2013.160. Epub 2013 Oct 29.</citation>
    <PMID>24166242</PMID>
  </reference>
  <reference>
    <citation>Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.</citation>
    <PMID>15999284</PMID>
  </reference>
  <reference>
    <citation>Schoenfeld AJ, George AA, Bader JO, Caram PM Jr. Incidence and epidemiology of cervical radiculopathy in the United States military: 2000 to 2009. J Spinal Disord Tech. 2012 Feb;25(1):17-22. doi: 10.1097/BSD.0b013e31820d77ea.</citation>
    <PMID>21430568</PMID>
  </reference>
  <reference>
    <citation>Burkhardt BW, Brielmaier M, Schwerdtfeger K, Oertel JM. Clinical outcome following anterior cervical discectomy and fusion with and without anterior cervical plating for the treatment of cervical disc herniation-a 25-year follow-up study. Neurosurg Rev. 2018 Apr;41(2):473-482. doi: 10.1007/s10143-017-0872-6. Epub 2017 Jun 23.</citation>
    <PMID>28646343</PMID>
  </reference>
  <reference>
    <citation>Phillips FM, Lee JY, Geisler FH, Cappuccino A, Chaput CD, DeVine JG, Reah C, Gilder KM, Howell KM, McAfee PC. A prospective, randomized, controlled clinical investigation comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion. 2-year results from the US FDA IDE clinical trial. Spine (Phila Pa 1976). 2013 Jul 1;38(15):E907-18. doi: 10.1097/BRS.0b013e318296232f.</citation>
    <PMID>23591659</PMID>
  </reference>
  <reference>
    <citation>Gross AR, Hoving JL, Haines TA, Goldsmith CH, Kay T, Aker P, Bronfort G; Cervical Overview Group. A Cochrane review of manipulation and mobilization for mechanical neck disorders. Spine (Phila Pa 1976). 2004 Jul 15;29(14):1541-8. doi: 10.1097/01.brs.0000131218.35875.ed.</citation>
    <PMID>15247576</PMID>
  </reference>
  <reference>
    <citation>Quesnele JJ, Triano JJ, Noseworthy MD, Wells GD. Changes in vertebral artery blood flow following various head positions and cervical spine manipulation. J Manipulative Physiol Ther. 2014 Jan;37(1):22-31. doi: 10.1016/j.jmpt.2013.07.008. Epub 2013 Nov 15.</citation>
    <PMID>24239451</PMID>
  </reference>
  <reference>
    <citation>Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004 May-Jun;4(3):335-56. doi: 10.1016/j.spinee.2003.06.002.</citation>
    <PMID>15125860</PMID>
  </reference>
  <reference>
    <citation>Koes BW, Bouter LM, van Mameren H, Essers AH, Verstegen GJ, Hofhuizen DM, Houben JP, Knipschild PG. A randomized clinical trial of manual therapy and physiotherapy for persistent back and neck complaints: subgroup analysis and relationship between outcome measures. J Manipulative Physiol Ther. 1993 May;16(4):211-9.</citation>
    <PMID>8340715</PMID>
  </reference>
  <reference>
    <citation>Arnbak B, Jensen TS, Egund N, Zejden A, Horslev-Petersen K, Manniche C, Jurik AG. Prevalence of degenerative and spondyloarthritis-related magnetic resonance imaging findings in the spine and sacroiliac joints in patients with persistent low back pain. Eur Radiol. 2016 Apr;26(4):1191-203. doi: 10.1007/s00330-015-3903-0. Epub 2015 Jul 22.</citation>
    <PMID>26194456</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>May 16, 2019</last_update_submitted>
  <last_update_submitted_qc>May 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cervical Discogenic pain</keyword>
  <keyword>Cyriax manipulation</keyword>
  <keyword>Neck Pain Disability index</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03827135
org study id: RiphahIU Aisha Razzaq
nct id: NCT03827135
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this research is to find and compare the effect of traditional physical therapy
      and Cyriax manipulation on pain, range of motion and disability in patients with cervical
      discogenic pain. Randomized controlled trials done at Benazir Bhutto hospital, Rawalpindi .
      The sample size was 40. The subjects were divided in two groups, 20 subjects in traditional
      physical therapy group and 20 in Cyriax manipulation group. Study duration was of 6 months.
      Sampling technique applied was purposive non probability sampling technique. Only 25-45 years
      individual with cervical discogenic pain were included. Tools used in the study are Numeric
      pain rating scale (NPRS) and neck disablity index (NDI). Data was be analyzed through SPSS
      21.
Cervical disc displacement is a significant cause of neck and arm pain and disability in
      majority of individuals. It causes a great burden on physical, social and emotional quality
      of life of patients. The cervical disc herniation is characterized by prolapsed nucleus
      pulposus material through the annulus into the spinal canal. The local mechanical or chemical
      irritation of neural structures typically leads to symptoms of radiculopathy, head and neck
      pain or myelopathy. The disc bulge may be postero-central to compress the dura matter,
      causing multi segmental pain and affect the scapular area. It can also be postero-lateral
      causing the root signs, that have dermatomal behavior and affect the upper limb in specific
      pattern. Postero-central bulge can also shift to postero-lateral with symptoms shifting from
      centralization to radiculopathy.

      The State of U.S. Health: Burden of Diseases, Injuries and Risk Factors describes cervical
      pain among 5 most contributing factor in causing years lived in disability. the ratio
      tremendously increases after 40 years. Studies describing impact of chronic neck pain on
      general health care reveals 14% of patients reports grade II to grade IV neck pain with high
      pain intensity and disability.

      Disc displacement disorders are included among the mechanical causes of neck pain.
      Symptomatic disc displacements can occur at any age but have different clinical features
      depending on the age group. In young adults nucleus pulposus can involve which is rare in old
      age. Diagnoses can be established on clinical findings along with patient's history and the
      functional examination. Disc displacement can occur in postero-central and Postero- lateral
      displacement. Movement of the disc posteriorly causes stress on the posterior longitudinal
      ligament and also on the anterior part of the Dura mater. As a result of this the pain
      travels in more than one segment with dural reference. Pain occurs in trapezius and scapular
      area. This typical poster central displacement causes the pain symptoms centrally and
      bilaterally. Poster lateral movement of disc tissue inserts force on the nerve root, which
      causes a Segmental pain or root pain and Segmental paraesthesia. Disc displacement may be
      primary or secondary. Secondary poster lateral displacement is more common type of
      displacement. Patient previously having pain in different segments like neck, trapezius and
      scapular region now feels pain in the upper limb area. It occurs due to the lateral shifting
      of disc tissues.

      The goal of treatment in discogenic problems is to stop the conflict between the displaced
      disc material and affecting sensitive structure. Disc fragment may affect the Dura matter,
      nerve roots and intervertebral joints. Manipulations and traction brings back the disc
      material to its place. The choice depends on the displacement. Nuclear displacements are
      treated by traction while annular ones are by manipulations. Injection usually is done to
      help pain less spontaneous recovery. If there is too much postero-central displacement that
      it compresses the spinal cord then surgery usually is done.

      Physiotherapy Treatment protocol for cervical discogenic pain include muscle strengthening
      and to relieve stress on muscles. Cyriax manipulation is a systematic technique of
      manipulation for the disc prolapse. this study hypothesize that there is a difference between
      the effects of traditional physical therapy and cyriax manipulation for the discogenic
      problems. The objecvtive of this study is to find the effects of cyriax manipulation and to
      compare it with traditional physical therapy treatment in patients with cervical discogenic
      pain.

      Literature review A systematic and evidence based search of relevant literature was performed
      by utilizing PubMed and Google Scholar as search engines. Search term for the initial
      literature review was discogenic pain, prevalence of neck pain, financial burden of
      discogenic pain, causes of neck pain, pathophysiology of discogenic pain, treatment options
      for discogenic pain, manipulation, cyriax manipulation, short term effects of manipulation.
      The search was limited to papers in English preferably published since 2000 with full text
      available. Different studies were available regarding cervical manipulation and its effects
      but limited data was available regarding cyriax manipulation in recent years.

      In 2004, previously concluded 33 high quality RCTs in a Cochrane review on mobilization and
      manipulation of mechanical neck pain. There was strong evidence that mobilization or
      manipulations when combined with exercises are beneficial for acute or chronic neck pain with
      or without headache. 3 -11 sessions were compared against placebo.

      In literature June 2004, worked to find best evidence in a systematic review on efficacy of
      spinal manipulation and mobilization for low back pain and neck pain. They showed that there
      is moderate evidence that spinal manipulative therapy for chronic neck pain is superior when
      compared to physical therapy and family physician care.

      Another randomized controlled trial to correlate the results of manual therapy,
      physiotherapy, general practitioner care, placebo in treatment of persistent neck and back
      pain. They took the patients well defined in sub-groups. Physiotherapy included exercises,
      massage and modalities (heat, ultra-sound, short-wave diathermy). Manual therapy included
      spine mobilization and manipulation. General practitioner provided analgesics, posture
      correction, home exercises and bed rest. Placebo consisted of detuned shortwave diathermy and
      ultra-sound for 10 mines.).Changes in severity of chief complain and functional limitation
      was main outcome measured by blinded research assistant. Results shows that manual therapy is
      significantly better than other sub-groups in chronic conditions younger than 40 years of
      age.

      In 2015, in a Cochrane systematic review on mobilization and manipulation on neck pain showed
      immediate effects of a single manipulation on sub-acute to chronic neck pain. Multiple
      sessions of cervical manipulations on acute and chronic neck pain produce immediate and long
      term effects on the pain, function and quality of life.

      Howe et al suggested that Manipulation produced a significant immediate improvement in
      symptoms in those with pain or stiffness in the neck, and pain/paraesthesia in the shoulder,
      and a nearly significant improvement in those with pain/paraesthesia in the arm/hand.

      Study on the non-surgical treatment of cervical radiculopathy suggest manipulation to be very
      effective and safe in reducing pain, hypo-mobility and disability.

      Randomized clinical trial suggest in their current randomized clinical trial that cervical
      and thoracic thrust manipulation induce similar changes in Pressure Pain Threshold,(PPT) neck
      pain intensity, and CROM in individuals with bilateral chronic mechanical neck pain.

      The combination of manual therapy and manipulation provide better results than manual therapy
      alone.

      Compared intensive training, physiotherapy and manipulation for patients with chronic neck
      pain after 6 months and 1 year follow up. They found that there was no significant difference
      between the three treatments. They suggested that as it is not clear whether it is the result
      of treatment or effect of time. Future studies are necessary to find out the exact treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Neck disability index
time frame: 4th Day
description: Changes from base line Northwick disability index was developed first in Northwick Park hospital, England. It was designed to measure the neck pain and disability over time. It consists of 10, five parts sections. At the end, score is calculated by dividing the obtained score by total (50) multiplied by 100. As the driving section was missing in all the female patients, total score was considered as 45 instead of 50.
measure: NPRS
time frame: 4th Day
description: Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
measure: ROM Cervical Spine ( Flexion)
time frame: 4th Day
description: Changes from the Baseline ROM range of Motion of Cervical spine flexion was taken with the Help of Goniometer
measure: ROM Cervical Spine ( extension)
time frame: 4th Day
description: Changes from the Baseline ROM range of Motion of Cervical spine extension was taken with the Help of Goniometer
measure: ROM Cervical Spine ( Right side flexion)
time frame: 4th Day
description: Changes from the Baseline ROM range of Motion of Cervical spine right side flexion was taken with the Help of Goniometer
measure: ROM Cervical Spine ( left side Flexion)
time frame: 4th Day
description: Changes from the Baseline ROM range of Motion of Cervical spine left side flexion was taken with the Help of Goniometer
measure: ROM Cervical Spine ( right rotation)
time frame: 4th Day
description: Changes from the Baseline ROM range of Motion of Cervical spine right rotation was taken with the Help of Goniometer
measure: ROM Cervical Spine ( left rotation)
time frame: 4th Day
description: Changes from the Baseline ROM range of Motion of Cervical spine left rotation was taken with the Help of Goniometer
arm group label: Traditional physical therapy
arm group type: Active Comparator
description: Cervical isometrics and Muscle Stretching
arm group label: Cyriax manipulation
arm group type: Experimental
description: Experimental group was given cyriax manipulation protocol along with the cervical isometrics and muscle stretching.
intervention type: Other
intervention name: Traditional physical therapy
description: Cervical isometrics 10 repetitions×1 set, 4 days/week and targeted muscle strechings (trapezius, scalenes and sternocleidomastoid) 10 repetitions×1 set, 4 days/week.
Total of 4 sessions were given each consisting of 40 mins.
arm group label: Traditional physical therapy
intervention type: Other
intervention name: Cyriax manipulation
description: Experimental group was given cyriax manipulation protocol along with the cervical isometrics and muscle strechings.
Traction with rotation was not given in cases of bilateral arm pain. cervical isometrics 10 repetitions×1 set, 4 days/week and targeted muscle strechings (trapezius, scalenes and sternocleidomastoid) 10 repetitions×1 set, 4 days/week.
Total of 4 sessions were given each consisting of 40 mins.
arm group label: Cyriax manipulation
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 45 Years
healthy volunteers: No
last name: Abdul Ghafoor Sajjad, PHD*
role: Principal Investigator
affiliation: Riphah International University
facility: 
country: Pakistan
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PMID: 24166242
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PMID: 15999284
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PMID: 21430568
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PMID: 28646343
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PMID: 23591659
citation: Gross AR, Hoving JL, Haines TA, Goldsmith CH, Kay T, Aker P, Bronfort G; Cervical Overview Group. A Cochrane review of manipulation and mobilization for mechanical neck disorders. Spine (Phila Pa 1976). 2004 Jul 15;29(14):1541-8. doi: 10.1097/01.brs.0000131218.35875.ed.
PMID: 15247576
citation: Quesnele JJ, Triano JJ, Noseworthy MD, Wells GD. Changes in vertebral artery blood flow following various head positions and cervical spine manipulation. J Manipulative Physiol Ther. 2014 Jan;37(1):22-31. doi: 10.1016/j.jmpt.2013.07.008. Epub 2013 Nov 15.
PMID: 24239451
citation: Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004 May-Jun;4(3):335-56. doi: 10.1016/j.spinee.2003.06.002.
PMID: 15125860
citation: Koes BW, Bouter LM, van Mameren H, Essers AH, Verstegen GJ, Hofhuizen DM, Houben JP, Knipschild PG. A randomized clinical trial of manual therapy and physiotherapy for persistent back and neck complaints: subgroup analysis and relationship between outcome measures. J Manipulative Physiol Ther. 1993 May;16(4):211-9.
PMID: 8340715
citation: Arnbak B, Jensen TS, Egund N, Zejden A, Horslev-Petersen K, Manniche C, Jurik AG. Prevalence of degenerative and spondyloarthritis-related magnetic resonance imaging findings in the spine and sacroiliac joints in patients with persistent low back pain. Eur Radiol. 2016 Apr;26(4):1191-203. doi: 10.1007/s00330-015-3903-0. Epub 2015 Jul 22.
PMID: 26194456
responsible party type: Sponsor
sharing ipd: No