NCT05404646

Brief Summary

The study will be a randomized clinical trial with a sample size of 44 to determine the effects of thoracic mobility versus thoracic stretching exercises on pain, range of motion, and function in patients with cervical radiculopathy. Subjects will be enrolled according to inclusion-exclusion criteria. Patients will be divided into two groups, each with 22 patients. Group A will receive thoracic mobility exercises along with conventional physical therapy while group B will receive thoracic stretching exercises along with the conventional physical therapy protocol. The conventional physical therapy protocol will include a hot pack, neck Traction, and stretches. The session will be around 30 to 45 min for each patient with three sessions per week on alternate days. A total of Three weeks of treatment regime will be given to the patients and an assessment of patient's pain, range of motion, and function with the Numeric Pain Rating Scale (NPRS), goniometry and Neck Disability Index (NDI) will be done at the baseline, after the completion of treatment at three weeks and after six weeks to observe the long-term effects. will be analyzed by using SPSS version 25

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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 31, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

June 15, 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 31, 2022

Last Update Submit

March 31, 2023

Conditions

Keywords

Cervical radiculopathyThoracic spineThoracic mobilizationStretching exercise

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale

    The Numeric Pain Rating Scale (NPRS) is a popular method to assess pain. The Numeric Pain Rating Scale (NPRS), asks the patient to quantify their pain on scale from 0 to 10 using whole Arabic numbers. On this 0 refers the no pain and 10 refers the highest pain.

    3rd Week

  • Neck Disability index

    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

    3rd Week

  • Range of Motion

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

    3rd Week

Study Arms (2)

Group A

EXPERIMENTAL

Thoracic mobility exercises

Other: Thoracic mobility exercises with conventional physical therapy for cervical radiculopathy

Group B

EXPERIMENTAL

Thoracic stretching exercises

Other: Thoracic stretching exercises with conventional physical therapy for cervical radiculopathy

Interventions

Thoracic mobility exercises These techniques include mobilization, manipulation and glides to check and treat the joints. Here, these techniques will be used to mobilize the thoracic spine. In this treatment mobility exercises (Unilateral posterior anterior, Central posterior anterior and transverse glides) + hot pack (10 min) + neck stretching (neck flexors, extensors, side benders) + cervical Traction will be given to patient. A total session time will be 45 min and thrice a week on alternate days for three weeks.

Group A

Thoracic stretching exercises Thoracic stretching exercises. Thoracic stretching exercises are used to correct the musculature of thoracic region. In this treatment group stretching exercises (passive stretches and therapist facilitated exercises) +hot pack (10 min) +neck stretching (neck flexors, extensors, side benders) + tractions will be given to patient. A total of 45 min session thrice a week on alternate days for three weeks will be given. Only the eligible patients who fulfil the inclusion criteria will be included in the study.

Group B

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders
  • Age 25-55 years
  • Unilateral cervical ridiculer pain.
  • Chronicity of pain - 4 weeks minimum.
  • Met wainner et al criteria (Slump test, Distraction test, ULTT)

You may not qualify if:

  • Fractures
  • Red Flags
  • Rheumatoid arthritis
  • Neurologic deficit
  • Injury to spinal cord
  • Tumor
  • Circulatory disturbances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District Head Quarter Bahawalnagar

Bahāwalnagar, Punjab Province, Pakistan

Location

Related Publications (10)

  • Kang KC, Lee HS, Lee JH. Cervical Radiculopathy Focus on Characteristics and Differential Diagnosis. Asian Spine J. 2020 Dec;14(6):921-930. doi: 10.31616/asj.2020.0647. Epub 2020 Dec 22.

    PMID: 33373515BACKGROUND
  • Mansfield M, Smith T, Spahr N, Thacker M. Cervical spine radiculopathy epidemiology: A systematic review. Musculoskeletal Care. 2020 Dec;18(4):555-567. doi: 10.1002/msc.1498. Epub 2020 Jul 25.

    PMID: 32710604BACKGROUND
  • Alshami AM, Bamhair DA. Effect of manual therapy with exercise in patients with chronic cervical radiculopathy: a randomized clinical trial. Trials. 2021 Oct 18;22(1):716. doi: 10.1186/s13063-021-05690-y.

    PMID: 34663421BACKGROUND
  • Liang L, Feng M, Cui X, Zhou S, Yin X, Wang X, Yang M, Liu C, Xie R, Zhu L, Yu J, Wei X. The effect of exercise on cervical radiculopathy: A systematic review and meta-analysis. Medicine (Baltimore). 2019 Nov;98(45):e17733. doi: 10.1097/MD.0000000000017733.

    PMID: 31702624BACKGROUND
  • Hassan F, Osama M, Ghafoor A, Yaqoob MF. Effects of oscillatory mobilization as compared to sustained stretch mobilization in the management of cervical radiculopathy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2020;33(1):153-158. doi: 10.3233/BMR-170914.

    PMID: 31127753BACKGROUND
  • Heneghan NR, Lokhaug SM, Tyros I, Longvastol S, Rushton A. Clinical reasoning framework for thoracic spine exercise prescription in sport: a systematic review and narrative synthesis. BMJ Open Sport Exerc Med. 2020 Mar 29;6(1):e000713. doi: 10.1136/bmjsem-2019-000713. eCollection 2020.

    PMID: 32341799BACKGROUND
  • Ali AA, Sheikh N, Chughani V, Hussain A, Rafique M, Ismail M, et al. Comparision of Effectiveness of Isometric and Stretching Exercise in Pain Management among the Forward Head Posture Patients. Indian Journal of Physiotherapy & Occupational Therapy. 2021;15(2).

    BACKGROUND
  • Young IA, Pozzi F, Dunning J, Linkonis R, Michener LA. Immediate and Short-term Effects of Thoracic Spine Manipulation in Patients With Cervical Radiculopathy: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2019 May;49(5):299-309. doi: 10.2519/jospt.2019.8150. Epub 2019 Apr 25.

    PMID: 31021691BACKGROUND
  • Langevin P, Desmeules F, Lamothe M, Robitaille S, Roy JS. Comparison of 2 manual therapy and exercise protocols for cervical radiculopathy: a randomized clinical trial evaluating short-term effects. J Orthop Sports Phys Ther. 2015 Jan;45(1):4-17. doi: 10.2519/jospt.2015.5211.

    PMID: 25420010BACKGROUND
  • Borrella-Andres S, Marques-Garcia I, Lucha-Lopez MO, Fanlo-Mazas P, Hernandez-Secorun M, Perez-Bellmunt A, Tricas-Moreno JM, Hidalgo-Garcia C. Manual Therapy as a Management of Cervical Radiculopathy: A Systematic Review. Biomed Res Int. 2021 Jun 3;2021:9936981. doi: 10.1155/2021/9936981. eCollection 2021.

    PMID: 34189141BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Syed Shakil-ur Rehman, 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

May 31, 2022

First Posted

June 3, 2022

Study Start

June 15, 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