Cervical RadiculopathyNCT05404646
Effects of Thoracic Mobility Versus Stretching Exercise Program in Patients of Cervical Radiculopathy
A study testing Thoracic mobility exercises with conventional physical therapy for cervical radiculopathy and Thoracic stretching exercises with conventional physical therapy for cervical radiculopathy in people with Cervical Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Thoracic mobility exercises with conventional physical therapy for cervical radiculopathy and Thoracic stretching exercises with conventional physical therapy for cervical radiculopathy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- • Fractures
- Red Flags
- Rheumatoid arthritis
- Neurologic deficit
- Injury to spinal cord
- Tumor
- Circulatory disturbances
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
District Head Quarter Bahawalnagar
Bahāwalnagar, Punjab Province
About this study
Official title: 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
Read the 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.
- Conditions
- Cervical Radiculopathy
- Being tested
- Thoracic mobility exercises with conventional physical therapy for cervical radiculopathy, Thoracic stretching exercises with conventional physical therapy for cervical radiculopathy
- Keywords
- Cervical radiculopathy, Thoracic spine, Thoracic mobilization, Stretching exercise
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic mobility exercises with conventional physical therapy for cervical radiculopathyOther
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.
Thoracic stretching exercises with conventional physical therapy for cervical radiculopathyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Thoracic mobility exercises Receives: Other: Thoracic mobility exercises with conventional physical therapy for cervical radiculopathy |
| Group B | Experimental | Thoracic stretching exercises Receives: Other: Thoracic stretching exercises with conventional physical therapy for cervical radiculopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 3rd Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start15 Jun 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil-ur Rehman, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404646
- Sponsor's protocol ID
- REC/RCR &AHS/22/0135 Iqra
- Status last verified
- Mar 2023
- First submitted
- 31 May 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33373515Mansfield 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.
PubMed 32710604Alshami 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.
PubMed 34663421Liang 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.
PubMed 31702624Hassan 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.
PubMed 31127753Heneghan 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.
PubMed 32341799Ali 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).
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.
PubMed 31021691Langevin 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.
PubMed 25420010Borrella-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.
PubMed 34189141
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Mobility Versus Stretching Exercise Program on Pain, Range of Motion and Function in Patients of Cervical Radiculopathy.
- ClinicalTrials.gov ID
- NCT05404646
- Acronym / sponsor ID
- REC/RCR &AHS/22/0135 Iqra
- Conditions
- Cervical Radiculopathy
- Keywords
- Cervical radiculopathy, Thoracic spine, Thoracic mobilization, Stretching exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Thoracic mobility exercises with conventional physical therapy for cervical radiculopathyThoracic mobility exercises |
| Group B | Experimental | Other: Thoracic stretching exercises with conventional physical therapy for cervical radiculopathyThoracic stretching exercises |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- • Fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic mobility exercises with conventional physical therapy for cervical radiculopathyThoracic 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. | Other | Group A |
| Thoracic stretching exercises with conventional physical therapy for cervical radiculopathyThoracic 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. | Other | Group B |
Primary outcome
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 33373515Kang 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.
- Background: PubMed 32710604Mansfield 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.
- Background: PubMed 34663421Alshami 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.
- Background: PubMed 31702624Liang 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.
- Background: PubMed 31127753Hassan 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.
- Background: PubMed 32341799Heneghan 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.
- BackgroundAli 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: PubMed 31021691Young 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.
- Background: PubMed 25420010Langevin 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.
- Background: PubMed 34189141Borrella-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Shakil-ur Rehman, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic mobility exercises with conventional physical therapy for cervical radiculopathy and Thoracic stretching exercises with conventional physical therapy for cervical radiculopathy in people with Cervical Radiculopathy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 3rd Week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404646, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.