NCT05393323

Brief Summary

The aim of this study is to compare the effects of cervical distraction versus cervical traction techniques on pain, range of motion and function in patients with upper cervical pain. This study will be randomized clinical trial and 42 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A will receive cervical distraction technique with conventional physical therapy while Group B will receive cervical traction technique with conventional therapy. Outcome measures; Neck Disability Index, goniometry and Numeric Pain Rating Scale will measure neck function and neck pain intensity. Both groups will receive 5 sessions per week for 4 weeks and measurements will be taken at the baseline and at the end of 4th week. Data will be analyzed by SPSS version 25

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

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

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

March 31, 2023

Conditions

Keywords

Cervical painTractionDistraction

Outcome Measures

Primary Outcomes (3)

  • NPRS

    The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain

    4th week

  • NDI

    The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. The maximum score is 50.

    4th Week

  • Goniometric measurement

    The science of measuring the joint ranges in each plane of the joint is called goniometry. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. Neck flexion, extension, side bending and rotation will be assessed through it

    4th Week

Study Arms (2)

Distraction technique

EXPERIMENTAL

conventional physical therapy with distraction technique

Other: conventional physical therapy with distraction technique

Traction technique

EXPERIMENTAL

conventional physical therapy with traction technique

Other: conventional physical therapy with traction technique

Interventions

Distraction will be at suboccipital level and patients will ask to assume a supine position with the head on the plinth. The therapist will use fingertips in both hands from digits 2 through 5, and cups the suboccipital region of the patient and supports the posterior skull. The therapist provides a light distraction to the posterior skull. Distraction will be applied for 10 min with pull for 10 sec and5 sec will be applied. Prior to apply this technique all patients will receive 15 minutes of infrared with TENS at cervical spine. The total treatment session will be of 25 minute with total intervention period of 4 weeks with 5 sessions per week.

Distraction technique

In cervical traction, patients will ask to lie supine on the treatment table. Head will cradle by physiotherapist from chin and the occiput, and then the physiotherapist will apply traction force in 25 degree neck flexion. Traction will be applied for 10 minutes with pull for 10 sec and 5 sec rest will be applied. Prior to apply this technique all patients will receive 15 minutes of infrared with TENS at cervical spine. The total treatment session will be of 25 min with total intervention period of 4 weeks with 5 sessions per week. All outcome measurements will be assessed before treatment and then reassessed at the end of 4th week.

Traction technique

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Minimum 3 months chronicity of upper cervical pain
  • Positive flexion-rotation test (asymmetry of \>10◦ between sides or less than 32◦ in any direction)
  • hypomobility in one or more segments of C0-1, C1-2, or C2-3

You may not qualify if:

  • Congenital abnormalities (Cervical torticollis)
  • Past surgical history of cervical spine
  • Any history of neck trauma
  • Already undergone physiotherapy treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmooda begum medical complex

Faisalābad, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • Vaishy S, Kondal S. Effect of Vertical Cervical traction Combined with Conventional Neurodynamic Mobilization and SNAGs in an Individual with Neck Pain and Cervical Radiculopathy: A Case Report.

    BACKGROUND
  • Khan K, Yasmeen S, Ishaque F, Imdad F, Shaikh SA, Nawaz U, et al. A RANDOMIZED CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY OF MANUAL TRACTION ON PAIN AND RANGE OF MOTION IN CERVICAL RADICULOPATHY.

    BACKGROUND
  • Popescu A, Lee H. Neck Pain and Lower Back Pain. Med Clin North Am. 2020 Mar;104(2):279-292. doi: 10.1016/j.mcna.2019.11.003. Epub 2019 Dec 20.

    PMID: 32035569BACKGROUND
  • Windsor RE, Malanga G, Benjamin M, Chawla J. Cervical spine anatomy. Medscape; 2017.

    BACKGROUND
  • Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.

    PMID: 29480409BACKGROUND
  • Sillevis R, Hogg R. Anatomy and clinical relevance of sub occipital soft tissue connections with the dura mater in the upper cervical spine. PeerJ. 2020 Aug 10;8:e9716. doi: 10.7717/peerj.9716. eCollection 2020.

    PMID: 32864219BACKGROUND
  • Fredin K, Loras H. Manual therapy, exercise therapy or combined treatment in the management of adult neck pain - A systematic review and meta-analysis. Musculoskelet Sci Pract. 2017 Oct;31:62-71. doi: 10.1016/j.msksp.2017.07.005. Epub 2017 Jul 21.

    PMID: 28750310BACKGROUND
  • Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.

    PMID: 34900443BACKGROUND
  • Rodriguez-Sanz J, Malo-Urries M, Corral-de-Toro J, Lopez-de-Celis C, Lucha-Lopez MO, Tricas-Moreno JM, Lorente AI, Hidalgo-Garcia C. Does the Addition of Manual Therapy Approach to a Cervical Exercise Program Improve Clinical Outcomes for Patients with Chronic Neck Pain in Short- and Mid-Term? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Sep 10;17(18):6601. doi: 10.3390/ijerph17186601.

    PMID: 32927858BACKGROUND
  • Afzal R, Ghous M, Shakil Ur Rehman S, Masood T. Comparison between Manual Traction, Manual Opening technique and Combination in Patients with cervical radiculopathy: Randomized Control Trial. J Pak Med Assoc. 2019 Sep;69(9):1237-1241.

    PMID: 31511705BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Syed Shakil-ur Rehman

    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

May 23, 2022

First Posted

May 26, 2022

Study Start

May 30, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations