Effects of Thoracic Mobility Versus Stretching Exercise Program in Patients of Cervical Radiculopathy

March 31, 2023 updated by: Riphah International University

Effects of Thoracic Mobility Versus Stretching Exercise Program on Pain, Range of Motion and Function in Patients of Cervical Radiculopathy.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cervical radiculopathy is characterized by neurological dysfunction caused by compression and inflammation of the spinal nerves or nerve roots of the cervical spine. The incidence and prevalence rate of cervical radiculopathy are unclear, and epidemiological data are limited.

Depending on the segments involved and the severity of neurological dysfunction, various signs and symptoms of cervical radiculopathy may manifest as neck and unilateral arm pain with numbness, weakness, or altered reflexes. Cervical spine radiculopathy is a disabling condition that has significant negative impacts on a person's mental health, physical functioning and social participation. It is a complex presentation, associated with increased dependence on healthcare systems, and poses a substantial challenge for clinicians and patients as it does not always respond to conventional therapies Symptoms of cervical radiculopathy may include neck and upper limb pain as well as neurological signs such as muscle weakness, disturbed sensation, and decreased reflex.

Patients with cervical radiculopathy demonstrated characteristics of sensory changes such as hypoesthesia (mechanical, thermal, and vibratory) and cold and pressure pain hypersensitivity. Conservative treatment, particularly physical therapy, is generally recommended as initial treatment for patients with cervical radiculopathy. It is found that vertebral mobilization and manipulation of the cervical spine were effective in improving pain, neck movement, and function in patients with cervical radiculopathy.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Bahāwalnagar, Punjab, Pakistan
        • District Head Quarter Bahawalnagar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • 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)

Exclusion Criteria:

  • • Fractures

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Thoracic mobility exercises
Other: Thoracic mobility exercises with conventional physical therapy for cervical radiculopathy
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.
Experimental: Group B
Thoracic stretching exercises
Other: Thoracic stretching exercises with conventional physical therapy for cervical radiculopathy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: 3rd Week
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
Time Frame: 3rd Week
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
Time Frame: 3rd Week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Syed Shakil-ur Rehman, PhD, Riphah international university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

January 30, 2023

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR &AHS/22/0135 Iqra

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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