Back PainNCT05347251
Effects of Cervicothoracic Mobility Program on Low Back Pain
A study testing Cervicothoracic mobility program and Conventional Treatment in people with Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be a randomized control trial to determine the effects of the cervicothoracic mobility program on pain, range of motion, and function in patients with chronic back pain. The purposive sampling technique will be used. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Cervicothoracic mobility program and Conventional Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Apr 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders.
- Age 18-50 years. NPRS between 3 and 6
- Subjects diagnosed with chronic back pain with minimum 6 months of chronicity
- ODI score 21 to 40
- There should be no radiating pain to legs of participants.
Who cannot join
- Patients with Systemic soft tissue disease and bony disease will be excluded from the study.
- Pregnant women will be excluded from the study.
- Patients with previous orthopedic and neurosurgical surgery will be excluded from the study.
- Patients with any Red flags (Ankylosing spondylitis, spondylolisthesis, Slipped discs, spinal tumor, spinal stenosis, cauda equine syndrome, and spine infection) will be excluded.
- Patients with a positive Faber test for SIJ dysfunction will be excluded
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Physiotherapy department of Syed medical complex Sialkot
Sialkot
About this study
Official title: Effects of Cervicothoracic Mobility Program on Pain, Range of Motion and Function in Patients With Chronic Back Pain
The study will be a randomized control trial to determine the effects of the cervicothoracic mobility program on pain, range of motion, and function in patients with chronic back pain. The purposive sampling technique will be used. A sample of 44 patients will be taken and divided into two groups each with 22 patients. Group A will be the experimental group and group B will be the control group. The experimental group will receive cervical mobility and thoracic mobility along with conventional physical therapy protocols like hot packs and exercise therapy protocol. Group B will be the control group and will receive the conventional physical therapy protocol like the hot pack and exercise therapy protocol. Exercise therapy includes the strengthening and stretching exercises of both neck and back muscles.
The session will be around 40 to 45 min for each patient with three sessions per week on alternate days. A total of 3-week treatment program will be given to the patients and an assessment of the patient's pain, range of motion, and function with NPRS (numeric pain rating scale), goniometer, and ODI (Oswestry disability index) will be done at the baseline and after the completion of treatment at three weeks.
Read the detailed description
Chronic back pain is usually age-related, but can also result from a prior injury. The most common causes include arthritis of the spine, a sedentary lifestyle, and any injury or disc-related problems. Joint mobilization is a physical therapy technique designed to relieve pain and muscle spasms, release tension and improve flexibility in a joint. The aim of this study is to determine the effects of the cervicothoracic mobility program on pain, range of motion, and function in patients with chronic back pain. The study will be a randomized control trial to determine the effects of the cervicothoracic mobility program on pain, range of motion and function in patients with chronic back pain. The purposive sampling technique will be used. A sample of 44 patients will be taken and divided into two groups each with 22 patients. Group A will be the experimental group and group B will be the control group. The experimental group will receive cervical mobility and thoracic mobility along with conventional physical therapy protocols like a hot pack and exercise therapy protocol. Group B will be the control group and will receive the conventional physical therapy protocol like hot pack and exercise therapy protocol. Exercise therapy includes the strengthening and stretching exercises of both neck and back muscles. The session will be around of 40 to 45 min on each patient with three sessions per week on alternate days. A total of 3-week treatment program will be given to the patients and an assessment of the patient's pain, range of motion and function with NPRS (numeric pain rating scale), goniometer and ODI (Oswestry disability index) will be done at the baseline and after the completion of treatment at three weeks.
- Conditions
- Back Pain
- Being tested
- Cervicothoracic mobility program, Conventional Treatment
- Keywords
- Back pain, Cervical mobilization, Thoracic mobilization
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervicothoracic mobility programOther
Participants in this group will receive mobilization at a cervical and thoracic level along with conventional physical therapy protocol like Hot packs and exercise therapy.
At the cervical, PA glides (central) and transverse glides will be given for mobilization.
At thoracic, PA glides (central) and transverse glides will be given for mobilization.
Exercise therapy includes stretching and strengthening both cervical and thoracic muscles. At the cervical level, neck isometric (flexion, extension, side bending) will be given to patients to enhance strengthening, and neck
stretching exercises (flexors, extensors, side benders
and rotators) will perform as well. Similarly, at the thoracic
level, strengthening and stretching of thoracic muscle will be performed
Conventional TreatmentOther
It will be the control group. The participants who will be allocated in this group receive the only conventional physical therapy protocol (Hot pack and exercise therapy). Exercise therapy includes stretching and strengthening of neck and upper back muscles. At the cervical level, neck isometric (flexion, extension, side bending) will be given to patients to enhance strengthening, and neck stretching exercises (flexors,
extensors, side benders, and rotators) will perform
as well. Similarly at the thoracic level, strengthening and stretching of thoracic muscle will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Cervicothoracic mobility program Receives: Other: Cervicothoracic mobility program |
| Group B | Other | Conventional Treatment Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain
Measured: 3rd Week
ODI
The Oswestry Disability Index is an extremely important tool that researchers and disability evaluators use tomeasure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
Measured: 3rd Week
Goniometer
A goniometer is an instrument which measures the available range of motion at a joint.
(Also mention all information which ROM u want to check)
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 posted26 Apr 2022
- Study start25 Apr 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 (12)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies 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
- NCT05347251
- Sponsor's protocol ID
- REC/Lhr/22/0137 Amna
- Status last verified
- Mar 2023
- First submitted
- 21 Apr 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
Husky MM, Ferdous Farin F, Compagnone P, Fermanian C, Kovess-Masfety V. Chronic back pain and its association with quality of life in a large French population survey. Health Qual Life Outcomes. 2018 Sep 26;16(1):195. doi: 10.1186/s12955-018-1018-4.
PubMed 30257670Ganesan S, Acharya AS, Chauhan R, Acharya S. Prevalence and Risk Factors for Low Back Pain in 1,355 Young Adults: A Cross-Sectional Study. Asian Spine J. 2017 Aug;11(4):610-617. doi: 10.4184/asj.2017.11.4.610. Epub 2017 Aug 7.
PubMed 28874980Sung YB, Lee JH, Park YH. Effects of thoracic mobilization and manipulation on function and mental state in chronic lower back pain. J Phys Ther Sci. 2014 Nov;26(11):1711-4. doi: 10.1589/jpts.26.1711. Epub 2014 Nov 13.
PubMed 25435683Rubinstein SM, de Zoete A, van Middelkoop M, Assendelft WJJ, de Boer MR, van Tulder MW. Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials. BMJ. 2019 Mar 13;364:l689. doi: 10.1136/bmj.l689.
PubMed 30867144Khan S, Al Torairi N, Shamsi S. Comparative Study Of Snags And Maitland's Mobilization In Chronic Low Back Pain. European Journal of Physical Education and Sport Science. 2018.
Sahin N, Karahan AY, Albayrak I. Effectiveness of physical therapy and exercise on pain and functional status in patients with chronic low back pain: a randomized-controlled trial. Turk J Phys Med Rehabil. 2017 Aug 9;64(1):52-58. doi: 10.5606/tftrd.2018.1238. eCollection 2018 Mar.
PubMed 31453489Divya, Parveen A, Nuhmani S, Ejaz Hussain M, Hussain Khan M. Effect of lumbar stabilization exercises and thoracic mobilization with strengthening exercises on pain level, thoracic kyphosis, and functional disability in chronic low back pain. J Complement Integr Med. 2020 Jul 27;18(2):419-424. doi: 10.1515/jcim-2019-0327.
PubMed 32712591Thomas JS, Clark BC, Russ DW, France CR, Ploutz-Snyder R, Corcos DM; RELIEF Study Investigators. Effect of Spinal Manipulative and Mobilization Therapies in Young Adults With Mild to Moderate Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2012589. doi: 10.1001/jamanetworkopen.2020.12589.
PubMed 32756930Lim C-G. Comparison of the effects of joint mobilization, gym ball exercises, and breathing exercises on breathing pattern disorders and joint position sense in persons with chronic low back pain. Physical Therapy Rehabilitation Science. 2020;9(1):25-35.
Herman PM, Whitley MD, Ryan GW, Hurwitz EL, Coulter ID. The impact of patient preferences and costs on the appropriateness of spinal manipulation and mobilization for chronic low back pain and chronic neck pain. BMC Musculoskelet Disord. 2019 Nov 7;20(1):519. doi: 10.1186/s12891-019-2904-6.
PubMed 31699077Yang D, Park S, Kang J, Kim J, Jung D, Kim Y, et al. The effect of spine mobilization technique on balance and the low back pain disability index of patients with chronic back pain. Journal of The Korean Society of Integrative Medicine. 2018;6(4):139-48
Naseer A, Ur Rehman SS, Fatima G, Ikram M. Effects of cervicothoracic mobility programme on pain, range of motion and function in patients with chronic back pain. J Pak Med Assoc. 2024 Jul;74(7):1291-1295. doi: 10.47391/JPMA.10939.
PubMed 39028057
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 Cervicothoracic Mobility Program on Pain, Range of Motion and Function in Patients With Chronic Back Pain
- ClinicalTrials.gov ID
- NCT05347251
- Acronym / sponsor ID
- REC/Lhr/22/0137 Amna
- Conditions
- Back Pain
- Keywords
- Back pain, Cervical mobilization, Thoracic mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 26 Apr 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 control trial to determine the effects of the cervicothoracic mobility program on pain, range of motion, and function in patients with chronic back pain. The purposive sampling technique will be used. A sample of 44 patients will be taken and divided into two groups each with 22 patients. Group A will be the experimental group and group B will be the control group. The experimental group will receive cervical mobility and thoracic mobility along with conventional physical therapy protocols like hot packs and exercise therapy protocol. Group B will be the control group and will receive the conventional physical therapy protocol like the hot pack and exercise therapy protocol. Exercise therapy includes the strengthening and stretching exercises of both neck and back muscles.
The session will be around 40 to 45 min for each patient with three sessions per week on alternate days. A total of 3-week treatment program will be given to the patients and an assessment of the patient's pain, range of motion, and function with NPRS (numeric pain rating scale), goniometer, and ODI (Oswestry disability index) will be done at the baseline and after the completion of treatment at three weeks.
Detailed description
Chronic back pain is usually age-related, but can also result from a prior injury. The most common causes include arthritis of the spine, a sedentary lifestyle, and any injury or disc-related problems. Joint mobilization is a physical therapy technique designed to relieve pain and muscle spasms, release tension and improve flexibility in a joint. The aim of this study is to determine the effects of the cervicothoracic mobility program on pain, range of motion, and function in patients with chronic back pain. The study will be a randomized control trial to determine the effects of the cervicothoracic mobility program on pain, range of motion and function in patients with chronic back pain. The purposive sampling technique will be used. A sample of 44 patients will be taken and divided into two groups each with 22 patients. Group A will be the experimental group and group B will be the control group. The experimental group will receive cervical mobility and thoracic mobility along with conventional physical therapy protocols like a hot pack and exercise therapy protocol. Group B will be the control group and will receive the conventional physical therapy protocol like hot pack and exercise therapy protocol. Exercise therapy includes the strengthening and stretching exercises of both neck and back muscles. The session will be around of 40 to 45 min on each patient with three sessions per week on alternate days. A total of 3-week treatment program will be given to the patients and an assessment of the patient's pain, range of motion and function with NPRS (numeric pain rating scale), goniometer and ODI (Oswestry disability index) will be done at the baseline and after the completion of treatment at three weeks.
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: Cervicothoracic mobility programCervicothoracic mobility program |
| Group B | Other | Other: Conventional TreatmentConventional Treatment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both genders.
- Age 18-50 years. NPRS between 3 and 6
- Subjects diagnosed with chronic back pain with minimum 6 months of chronicity
- ODI score 21 to 40
- There should be no radiating pain to legs of participants.
Key exclusion criteria (5 listed)
- Patients with Systemic soft tissue disease and bony disease will be excluded from the study.
- Pregnant women will be excluded from the study.
- Patients with previous orthopedic and neurosurgical surgery will be excluded from the study.
- Patients with any Red flags (Ankylosing spondylitis, spondylolisthesis, Slipped discs, spinal tumor, spinal stenosis, cauda equine syndrome, and spine infection) will be excluded.
- Patients with a positive Faber test for SIJ dysfunction will be excluded
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 |
|---|---|---|
| Cervicothoracic mobility programParticipants in this group will receive mobilization at a cervical and thoracic level along with conventional physical therapy protocol like Hot packs and exercise therapy. At the cervical, PA glides (central) and transverse glides will be given for mobilization. At thoracic, PA glides (central) and transverse glides will be given for mobilization. Exercise therapy includes stretching and strengthening both cervical and thoracic muscles. At the cervical level, neck isometric (flexion, extension, side bending) will be given to patients to enhance strengthening, and neck stretching exercises (flexors, extensors, side benders and rotators) will perform as well. Similarly, at the thoracic level, strengthening and stretching of thoracic muscle will be performed | Other | Group A |
| Conventional TreatmentIt will be the control group. The participants who will be allocated in this group receive the only conventional physical therapy protocol (Hot pack and exercise therapy). Exercise therapy includes stretching and strengthening of neck and upper back muscles. At the cervical level, neck isometric (flexion, extension, side bending) will be given to patients to enhance strengthening, and neck stretching exercises (flexors, extensors, side benders, and rotators) will perform as well. Similarly at the thoracic level, strengthening and stretching of thoracic muscle will be performed. | Other | Group B |
Primary outcome
NPRS
Time frame: 3rd Week
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain
ODI
Time frame: 3rd Week
The Oswestry Disability Index is an extremely important tool that researchers and disability evaluators use tomeasure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
Goniometer
Time frame: 3rd Week
A goniometer is an instrument which measures the available range of motion at a joint. (Also mention all information which ROM u want to check)
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 30257670Husky MM, Ferdous Farin F, Compagnone P, Fermanian C, Kovess-Masfety V. Chronic back pain and its association with quality of life in a large French population survey. Health Qual Life Outcomes. 2018 Sep 26;16(1):195. doi: 10.1186/s12955-018-1018-4.
- Background: PubMed 28874980Ganesan S, Acharya AS, Chauhan R, Acharya S. Prevalence and Risk Factors for Low Back Pain in 1,355 Young Adults: A Cross-Sectional Study. Asian Spine J. 2017 Aug;11(4):610-617. doi: 10.4184/asj.2017.11.4.610. Epub 2017 Aug 7.
- Background: PubMed 25435683Sung YB, Lee JH, Park YH. Effects of thoracic mobilization and manipulation on function and mental state in chronic lower back pain. J Phys Ther Sci. 2014 Nov;26(11):1711-4. doi: 10.1589/jpts.26.1711. Epub 2014 Nov 13.
- Background: PubMed 30867144Rubinstein SM, de Zoete A, van Middelkoop M, Assendelft WJJ, de Boer MR, van Tulder MW. Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials. BMJ. 2019 Mar 13;364:l689. doi: 10.1136/bmj.l689.
- BackgroundKhan S, Al Torairi N, Shamsi S. Comparative Study Of Snags And Maitland's Mobilization In Chronic Low Back Pain. European Journal of Physical Education and Sport Science. 2018.
- Background: PubMed 31453489Sahin N, Karahan AY, Albayrak I. Effectiveness of physical therapy and exercise on pain and functional status in patients with chronic low back pain: a randomized-controlled trial. Turk J Phys Med Rehabil. 2017 Aug 9;64(1):52-58. doi: 10.5606/tftrd.2018.1238. eCollection 2018 Mar.
- Background: PubMed 32712591Divya, Parveen A, Nuhmani S, Ejaz Hussain M, Hussain Khan M. Effect of lumbar stabilization exercises and thoracic mobilization with strengthening exercises on pain level, thoracic kyphosis, and functional disability in chronic low back pain. J Complement Integr Med. 2020 Jul 27;18(2):419-424. doi: 10.1515/jcim-2019-0327.
- Background: PubMed 32756930Thomas JS, Clark BC, Russ DW, France CR, Ploutz-Snyder R, Corcos DM; RELIEF Study Investigators. Effect of Spinal Manipulative and Mobilization Therapies in Young Adults With Mild to Moderate Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2012589. doi: 10.1001/jamanetworkopen.2020.12589.
- BackgroundLim C-G. Comparison of the effects of joint mobilization, gym ball exercises, and breathing exercises on breathing pattern disorders and joint position sense in persons with chronic low back pain. Physical Therapy Rehabilitation Science. 2020;9(1):25-35.
- Background: PubMed 31699077Herman PM, Whitley MD, Ryan GW, Hurwitz EL, Coulter ID. The impact of patient preferences and costs on the appropriateness of spinal manipulation and mobilization for chronic low back pain and chronic neck pain. BMC Musculoskelet Disord. 2019 Nov 7;20(1):519. doi: 10.1186/s12891-019-2904-6.
- BackgroundYang D, Park S, Kang J, Kim J, Jung D, Kim Y, et al. The effect of spine mobilization technique on balance and the low back pain disability index of patients with chronic back pain. Journal of The Korean Society of Integrative Medicine. 2018;6(4):139-48
- Derived from this study: PubMed 39028057Naseer A, Ur Rehman SS, Fatima G, Ikram M. Effects of cervicothoracic mobility programme on pain, range of motion and function in patients with chronic back pain. J Pak Med Assoc. 2024 Jul;74(7):1291-1295. doi: 10.47391/JPMA.10939.
- 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 Cervicothoracic mobility program and Conventional Treatment in people with Back Pain, 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 5 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?
NPRS (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 NCT05347251, which also lists 12 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.