NCT03827135

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

5 months

First QC Date

January 27, 2019

Last Update Submit

May 16, 2019

Conditions

Cervical Discogenic Pain (Disorder)

Keywords

Cervical Discogenic painCyriax manipulationNeck Pain Disability index

Outcome Measures

Primary Outcomes (1)

  • 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.

    4th Day

Secondary Outcomes (7)

  • NPRS

    4th Day

  • ROM Cervical Spine ( Flexion)

    4th Day

  • ROM Cervical Spine ( extension)

    4th Day

  • ROM Cervical Spine ( Right side flexion)

    4th Day

  • ROM Cervical Spine ( left side Flexion)

    4th Day

  • +2 more secondary outcomes

Study Arms (2)

Traditional physical therapy

ACTIVE COMPARATOR

Cervical isometrics and Muscle Stretching

Other: Traditional physical therapy

Cyriax manipulation

EXPERIMENTAL

Experimental group was given cyriax manipulation protocol along with the cervical isometrics and muscle stretching.

Other: Cyriax manipulation

Interventions

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.

Traditional physical therapy
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.

Cyriax manipulation

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (10)

  • 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.

    PMID: 24166242BACKGROUND

  • 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.

    PMID: 15999284BACKGROUND

  • 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.

    PMID: 21430568BACKGROUND

  • 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.

    PMID: 28646343BACKGROUND

  • 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.

    PMID: 23591659BACKGROUND

  • 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: 15247576BACKGROUND

  • 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: 24239451BACKGROUND

  • 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: 15125860BACKGROUND

  • 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: 8340715BACKGROUND

  • 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: 26194456BACKGROUND

Study Officials

  • Abdul Ghafoor Sajjad, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2019

First Posted

February 1, 2019

Study Start

January 15, 2018

Primary Completion

June 20, 2018

Study Completion

June 30, 2018

Last Updated

May 20, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)