Cervical Discogenic Pain (Disorder)NCT03827135
Cyriax Manipulation in Cervical Discogenic Pain
A study testing Traditional physical therapy and Cyriax manipulation in people with Cervical Discogenic Pain (Disorder), run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Cervical Discogenic Pain (Disorder)
- What is being tested?
- Traditional physical therapy and Cyriax manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed and confirmed cases of cervical disco genic pain by Weiner's criteria and Cyriax clinical assessment,
- Discogenic cases with pain either in cervico-scapular area, radiating to arm without any neurological symptoms were the main objects of study.
Who cannot join
- Patients have vertebrobasilar insufficiency (tested by VBI tests),
- Altanto axial instability (tested by sharp purser test),
- Osteoporosis, Rheumatoid arthritis,
- Neuropathies,
- Recent surgeries and neuropathies were excluded from study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cyriax Manipulation in Cervical Discogenic Pain
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.
Read the detailed description
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.
- Conditions
- Cervical Discogenic Pain (Disorder)
- Being tested
- Traditional physical therapy, Cyriax manipulation
- Keywords
- Cervical Discogenic pain, Cyriax manipulation, Neck Pain Disability index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional physical therapyOther
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.
Cyriax manipulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional physical therapy | Active comparator | Cervical isometrics and Muscle Stretching Receives: Other: Traditional physical therapy |
| Cyriax manipulation | Experimental | Experimental group was given cyriax manipulation protocol along with the cervical isometrics and muscle stretching. Receives: Other: Cyriax manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck disability index
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.
Measured: 4th Day
Secondary outcomes (7)
NPRS
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.
Measured: 4th Day
ROM Cervical Spine ( Flexion)
Changes from the Baseline ROM range of Motion of Cervical spine flexion was taken with the Help of Goniometer
Measured: 4th Day
ROM Cervical Spine ( extension)
Changes from the Baseline ROM range of Motion of Cervical spine extension was taken with the Help of Goniometer
Measured: 4th Day
ROM Cervical Spine ( Right side flexion)
Changes from the Baseline ROM range of Motion of Cervical spine right side flexion was taken with the Help of Goniometer
Measured: 4th Day
ROM Cervical Spine ( left side Flexion)
Changes from the Baseline ROM range of Motion of Cervical spine left side flexion was taken with the Help of Goniometer
Measured: 4th Day
ROM Cervical Spine ( right rotation)
Changes from the Baseline ROM range of Motion of Cervical spine right rotation was taken with the Help of Goniometer
Measured: 4th Day
ROM Cervical Spine ( left rotation)
Changes from the Baseline ROM range of Motion of Cervical spine left rotation was taken with the Help of Goniometer
Measured: 4th Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start15 Jan 2018
- Primary completion20 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cervical Discogenic Pain (Disorder)Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdul Ghafoor Sajjad, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827135
- Sponsor's protocol ID
- RiphahIU Aisha Razzaq
- Status last verified
- May 2019
- First submitted
- 27 Jan 2019
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24166242Fejer 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.
PubMed 15999284Schoenfeld 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.
PubMed 21430568Burkhardt 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.
PubMed 28646343Phillips 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.
PubMed 23591659Gross 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.
PubMed 15247576Quesnele 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.
PubMed 24239451Bronfort 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.
PubMed 15125860Koes 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.
PubMed 8340715Arnbak 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.
PubMed 26194456
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cyriax Manipulation in Cervical Discogenic Pain
- ClinicalTrials.gov ID
- NCT03827135
- Acronym / sponsor ID
- RiphahIU Aisha Razzaq
- Conditions
- Cervical Discogenic Pain (Disorder)
- Keywords
- Cervical Discogenic pain, Cyriax manipulation, Neck Pain Disability index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional physical therapy | Active comparator | Other: Traditional physical therapyCervical isometrics and Muscle Stretching |
| Cyriax manipulation | Experimental | Other: Cyriax manipulationExperimental group was given cyriax manipulation protocol along with the cervical isometrics and muscle stretching. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed and confirmed cases of cervical disco genic pain by Weiner's criteria and Cyriax clinical assessment,
- Discogenic cases with pain either in cervico-scapular area, radiating to arm without any neurological symptoms were the main objects of study.
Key exclusion criteria (5 listed)
- Patients have vertebrobasilar insufficiency (tested by VBI tests),
- Altanto axial instability (tested by sharp purser test),
- Osteoporosis, Rheumatoid arthritis,
- Neuropathies,
- Recent surgeries and neuropathies were excluded from study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional physical therapyCervical 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. | Other | Traditional physical therapy |
| Cyriax manipulationExperimental 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. | Other | Cyriax manipulation |
Primary outcome
Neck disability index
Time frame: 4th Day
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.
7 secondary outcomes
NPRS
Time frame: 4th Day
ROM Cervical Spine ( Flexion)
Time frame: 4th Day
ROM Cervical Spine ( extension)
Time frame: 4th Day
ROM Cervical Spine ( Right side flexion)
Time frame: 4th Day
ROM Cervical Spine ( left side Flexion)
Time frame: 4th Day
ROM Cervical Spine ( right rotation)
Time frame: 4th Day
ROM Cervical Spine ( left rotation)
Time frame: 4th Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Background: PubMed 24166242Risbud 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.
- Background: PubMed 15999284Fejer 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.
- Background: PubMed 21430568Schoenfeld 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.
- Background: PubMed 28646343Burkhardt 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.
- Background: PubMed 23591659Phillips 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.
- Background: PubMed 15247576Gross 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.
- Background: PubMed 24239451Quesnele 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.
- Background: PubMed 15125860Bronfort 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.
- Background: PubMed 8340715Koes 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.
- Background: PubMed 26194456Arnbak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul Ghafoor Sajjad, PHD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional physical therapy and Cyriax manipulation in people with Cervical Discogenic Pain (Disorder), run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck disability index (time frame: 4th Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03827135, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.