Effects of Thoracic Mobility Versus Stretching Exercise Program in Patients of Cervical Radiculopathy
Primary Purpose
Cervical Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Thoracic mobility exercises with conventional physical therapy for cervical radiculopathy
Thoracic stretching exercises with conventional physical therapy for cervical radiculopathy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Cervical radiculopathy, Thoracic spine, Thoracic mobilization, Stretching exercise
Eligibility Criteria
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
Sites / Locations
- District Head Quarter Bahawalnagar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Thoracic mobility exercises
Thoracic stretching exercises
Outcomes
Primary Outcome Measures
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.
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05404646
First Posted
May 31, 2022
Last Updated
March 31, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05404646
Brief Title
Effects of Thoracic Mobility Versus Stretching Exercise Program in Patients of Cervical Radiculopathy
Official Title
Effects of Thoracic Mobility Versus Stretching Exercise Program on Pain, Range of Motion and Function in Patients of Cervical Radiculopathy.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
Cervical radiculopathy, Thoracic spine, Thoracic mobilization, Stretching exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Thoracic mobility exercises
Arm Title
Group B
Arm Type
Experimental
Arm Description
Thoracic stretching exercises
Intervention Type
Other
Intervention Name(s)
Thoracic mobility exercises with conventional physical therapy for cervical radiculopathy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Thoracic stretching exercises with conventional physical therapy for cervical radiculopathy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
3rd Week
Title
Neck Disability index
Description
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
Time Frame
3rd Week
Title
Range of Motion
Description
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
Time Frame
3rd Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil-ur Rehman, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
District Head Quarter Bahawalnagar
City
Bahāwalnagar
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33373515
Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
34663421
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Citation
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).
Results Reference
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PubMed Identifier
31021691
Citation
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.
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Citation
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.
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Citation
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Results Reference
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Effects of Thoracic Mobility Versus Stretching Exercise Program in Patients of Cervical Radiculopathy
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