Back PainNCT07063992
Effects of Thoracic Spine Manipulation With and Without Costovertebral Joint Manipulation in Patients Mid-back Pain
A study testing thoracic facet manipulations, thoracic facet and costovertebral manipulations and Standard Physiotherapy in people with Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Mid-back pain (mbp) is defined as pain occurring within the limits of the third thoracic (T3) and ninth thoracic (T9) vertebrae, caused by the dysfunction of the musculoskeletal structures in the thoracic spine. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Back Pain
- What is being tested?
- thoracic facet manipulations, thoracic facet and costovertebral manipulations and Standard Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jul 2025to 30 Oct 2025
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants will be between 18 - 45 years of age
- For this study, mid-back pain included all the following signs and symptoms:
- Sharp, shooting, or aching mid-back pain
- Mid back pain experienced during deep inspiration, sneezing, and/or coughing
Who cannot join
- Individuals who did not sign or understand the letter of informed consent
- Individuals with contraindications to manipulation in the thoracic spine (15)
- Weakened bone due to: Osteoporosis, Infection and Neoplasm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Thoracic Spine Manipulation With and Without Costovertebral Joint Manipulation in Patients With Non-specific Mid-back Pain
Mid-back pain (mbp) is defined as pain occurring within the limits of the third thoracic (T3) and ninth thoracic (T9) vertebrae, caused by the dysfunction of the musculoskeletal structures in the thoracic spine. It can present as pain and/or burning between the shoulder blades with reduced thoracic spine mobility and increased muscle tension. Congenital disorders such as scoliosis and Scheuermann's disease, or acquired disorders such as thoracic facet and costovertebral joint dysfunction may cause mid back pain.
Read the detailed description
Participants aged 18-45 years with non-specific mid-back pain will be randomly assigned to receive either thoracic spine manipulation alone or in combination with costovertebral joint manipulation. Primary outcomes will include pain intensity measured by the Numeric Pain Rating Scale (NPRS), while secondary outcomes will involve thoracic spine range of motion measured by Bubble Inclinometer, and functional disability assessed by the Oswestry Disability Index (ODI). Statistical analysis will be performed using the statistical software IBM SPSS Statistics SPSS 25.0 for calculations. This study aims to provide evidence-based insights into the relative benefits of these manual therapy techniques, potentially informing clinical practice and enhancing treatment outcomes for patients with non-specific mid-back pain.
- Conditions
- Back Pain
- Being tested
- thoracic facet manipulations, thoracic facet and costovertebral manipulations, Standard Physiotherapy
- Keywords
- Craniovertebral Angle, Mid-Back Pain, muscle strength
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic facet manipulationsOther
Group A will receive thoracic facet manipulations of the restricted segments between T3 to T9, in the prone position and cephalic direction. The duration of the intervention will be followed by 4 weeks 3 sessions each week and pre- and post-intervention observations will be recorded.
Bilateral hypothenar Cross bilateral hypothenar manipulation.
thoracic facet and costovertebral manipulationsOther
Group B will receive thoracic facet and costovertebral manipulations of the restricted segments between T3 to T9 and ribs 3 to 9 (costovertebral joints), in the prone position. The duration of the intervention will be followed by 4 weeks 3 sessions each week and pre and post-intervention observations will be recorded.
Hypothenar Costal Manipulative technique Ilial Hypothenar costal manipulation between T3-T9
Standard PhysiotherapyOther
Hot pack given for 10 minutes. Cervical spine given isometric exercises with 10 repetitions and 6 seconds hold.
These flexibility exercises will be targeted for
- Rhomboid and middle trapezius stretching (2-3 times daily; 3 sets for 30 seconds))
- Pectoralis muscle stretch in a corner (2-3 times daily; 3 sets for 30 seconds)
- Prone on the elbow with upper thoracic extension exercise (2-3 times daily; 3 sets for 30 seconds) .
The postural exercises will be the following
- Postural strengthening/ stabilization with back to a wall. The participant will press their arms into the wall while retracting scapulae.
- Trunk rotation stretching in the sitting position
| Study group | Role | What they receive |
|---|---|---|
| thoracic facet manipulations | Experimental | Group A will receive thoracic facet manipulations of the restricted segments between T3 to T9, in the prone position and cephalic direction. The duration of the intervention will be followed by 4 weeks 3 sessions each week and pre- and post-intervention observations will be recorded.
* Bilateral hypothenar
* Cross bilateral hypothenar manipulation Receives: Other: thoracic facet manipulations; Other: Standard Physiotherapy |
| thoracic facet and costovertebral manipulations | Experimental | Group B will receive thoracic facet and costovertebral manipulations of the restricted segments between T3 to T9 and ribs 3 to 9 (costovertebral joints), in the prone position. The duration of the intervention will be followed by 4 weeks 3 sessions each week and pre and post-intervention observations will be recorded.
* Hypothenar Costal Manipulative technique
* Ilial Hypothenar costal manipulation between T3-T9 Receives: Other: thoracic facet and costovertebral manipulations; Other: Standard Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) is perhaps the most frequently applied scale used to quantify pain intensity in the clinical setting. It is an 11-point numeric scale, ranging from 0 indicating no pain to 10 indicating worst pain imaginable.
Measured: upto 4 weeks
Oswestry Disability Index
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain and quality of life. Oswestry Disability Index. Purpose. used to qualify low back pain. Patients manage daily activities well, typically requiring only guidance on posture and exercise.21%-40% (Moderate Disability): Pain affects sitting, standing, lifting, and work, though personal care remains manageable.41%-60% (Severe Disability): Daily activities are heavily disrupted by persistent pain, prompting detailed clinical evaluation.61%-80% (Crippling/Severe Restriction): Back pain broadly limits daily and social functioning, requiring active medical intervention.81%-100%: Individuals are either bed-bound or experiencing extreme symptom exaggeration.
Measured: upto 4 weeks
Bubble Inclinometer
A bubble inclinometer is a simple, handheld device used to measure the angle of inclination or tilt of a surface. In the context of thoracic spine assessments, it is particularly useful for quantifying the range of motion and curvature of the spine.
Measured: upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start25 Jul 2025
- Primary completion20 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samrood Akram, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063992
- Sponsor's protocol ID
- REC/RCR &AHS/24/0142 Alishah
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cibulka M, Buck J, Busta B, Neil E, Smith D, Triller R. Intra and inter observer agreement in the mobility assessment of the upper thoracic costovertebral joints. Physiother Theory Pract. 2023 Sep 2;39(9):1993-1999. doi: 10.1080/09593985.2022.2058439. Epub 2022 Mar 27.
PubMed 35343374Koivunen K, Widbom-Kolhanen S, Pernaa K, Arokoski J, Saltychev M. Reliability and validity of Oswestry Disability Index among patients undergoing lumbar spinal surgery. BMC Surg. 2024 Jan 3;24(1):13. doi: 10.1186/s12893-023-02307-w.
PubMed 38172794Kirsten Elizabeth Petrie. E. K. (2019). Costovertebral Manipulation versus Ultrasound Therapy of Rhomboid Trigger Points and a Combination Thereof in Treating Inter-scapular Pain. PQDT-Global.
Honore M, Picchiottino M, Wedderkopp N, Leboeuf-Yde C, Gagey O. What is the effect of spinal manipulation on the pressure pain threshold in young, asymptomatic subjects? A randomized placebo-controlled trial, with a cross-over design. Chiropr Man Therap. 2020 Feb 7;28(1):6. doi: 10.1186/s12998-020-0296-1.
PubMed 32028982Masaracchio M, Kirker K, States R, Hanney WJ, Liu X, Kolber M. Thoracic spine manipulation for the management of mechanical neck pain: A systematic review and meta-analysis. PLoS One. 2019 Feb 13;14(2):e0211877. doi: 10.1371/journal.pone.0211877. eCollection 2019.
PubMed 30759118Honore M, Leboeuf-Yde C, Gagey O. The regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects: a systematic literature review. Chiropr Man Therap. 2018 Apr 19;26:11. doi: 10.1186/s12998-018-0181-3. eCollection 2018.
PubMed 29713457Tsegay GS, Gebregergs GB, Weleslassie GG, Hailemariam TT. Effectiveness of Thoracic Spine Manipulation on the Management of Neck Pain: A Systematic Review and Meta-Analysis of Randomized Control Trials. J Pain Res. 2023 Feb 27;16:597-609. doi: 10.2147/JPR.S368910. eCollection 2023.
PubMed 36875686
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Spine Manipulation With and Without Costovertebral Joint Manipulation in Patients With Non-specific Mid-back Pain
- ClinicalTrials.gov ID
- NCT07063992
- Acronym / sponsor ID
- REC/RCR &AHS/24/0142 Alishah
- Conditions
- Back Pain
- Keywords
- Craniovertebral Angle, Mid-Back Pain, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 14 Jul 2025 (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.
Mid-back pain (mbp) is defined as pain occurring within the limits of the third thoracic (T3) and ninth thoracic (T9) vertebrae, caused by the dysfunction of the musculoskeletal structures in the thoracic spine. It can present as pain and/or burning between the shoulder blades with reduced thoracic spine mobility and increased muscle tension. Congenital disorders such as scoliosis and Scheuermann's disease, or acquired disorders such as thoracic facet and costovertebral joint dysfunction may cause mid back pain.
Detailed description
Participants aged 18-45 years with non-specific mid-back pain will be randomly assigned to receive either thoracic spine manipulation alone or in combination with costovertebral joint manipulation. Primary outcomes will include pain intensity measured by the Numeric Pain Rating Scale (NPRS), while secondary outcomes will involve thoracic spine range of motion measured by Bubble Inclinometer, and functional disability assessed by the Oswestry Disability Index (ODI). Statistical analysis will be performed using the statistical software IBM SPSS Statistics SPSS 25.0 for calculations. This study aims to provide evidence-based insights into the relative benefits of these manual therapy techniques, potentially informing clinical practice and enhancing treatment outcomes for patients with non-specific mid-back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thoracic facet manipulations | Experimental | Other: thoracic facet manipulations, Other: Standard PhysiotherapyGroup A will receive thoracic facet manipulations of the restricted segments between T3 to T9, in the prone position and cephalic direction. The duration of the intervention will be followed by 4 weeks 3 sessions each week and pre- and post-intervention observations will be recorded. * Bilateral hypothenar * Cross bilateral hypothenar manipulation |
| thoracic facet and costovertebral manipulations | Experimental | Other: thoracic facet and costovertebral manipulations, Other: Standard PhysiotherapyGroup B will receive thoracic facet and costovertebral manipulations of the restricted segments between T3 to T9 and ribs 3 to 9 (costovertebral joints), in the prone position. The duration of the intervention will be followed by 4 weeks 3 sessions each week and pre and post-intervention observations will be recorded. * Hypothenar Costal Manipulative technique * Ilial Hypothenar costal manipulation between T3-T9 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants will be between 18 - 45 years of age
- For this study, mid-back pain included all the following signs and symptoms:
- Sharp, shooting, or aching mid-back pain
- Mid back pain experienced during deep inspiration, sneezing, and/or coughing
Key exclusion criteria (3 listed)
- Individuals who did not sign or understand the letter of informed consent
- Individuals with contraindications to manipulation in the thoracic spine (15)
- Weakened bone due to: Osteoporosis, Infection and Neoplasm
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 facet manipulationsGroup A will receive thoracic facet manipulations of the restricted segments between T3 to T9, in the prone position and cephalic direction. The duration of the intervention will be followed by 4 weeks 3 sessions each week and pre- and post-intervention observations will be recorded. Bilateral hypothenar Cross bilateral hypothenar manipulation. | Other | thoracic facet manipulations |
| thoracic facet and costovertebral manipulationsGroup B will receive thoracic facet and costovertebral manipulations of the restricted segments between T3 to T9 and ribs 3 to 9 (costovertebral joints), in the prone position. The duration of the intervention will be followed by 4 weeks 3 sessions each week and pre and post-intervention observations will be recorded. Hypothenar Costal Manipulative technique Ilial Hypothenar costal manipulation between T3-T9 | Other | thoracic facet and costovertebral manipulations |
| Standard PhysiotherapyHot pack given for 10 minutes. Cervical spine given isometric exercises with 10 repetitions and 6 seconds hold. These flexibility exercises will be targeted for * Rhomboid and middle trapezius stretching (2-3 times daily; 3 sets for 30 seconds)) * Pectoralis muscle stretch in a corner (2-3 times daily; 3 sets for 30 seconds) * Prone on the elbow with upper thoracic extension exercise (2-3 times daily; 3 sets for 30 seconds) . The postural exercises will be the following * Postural strengthening/ stabilization with back to a wall. The participant will press their arms into the wall while retracting scapulae. * Trunk rotation stretching in the sitting position | Other | thoracic facet and costovertebral manipulations, thoracic facet manipulations |
Primary outcome
Numerical Pain Rating Scale (NPRS)
Time frame: upto 4 weeks
The Numeric Pain Rating Scale (NPRS) is perhaps the most frequently applied scale used to quantify pain intensity in the clinical setting. It is an 11-point numeric scale, ranging from 0 indicating no pain to 10 indicating worst pain imaginable.
Oswestry Disability Index
Time frame: upto 4 weeks
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain and quality of life. Oswestry Disability Index. Purpose. used to qualify low back pain. Patients manage daily activities well, typically requiring only guidance on posture and exercise.21%-40% (Moderate Disability): Pain affects sitting, standing, lifting, and work, though personal care remains manageable.41%-60% (Severe Disability): Daily activities are heavily disrupted by persistent pain, prompting detailed clinical evaluation.61%-80% (Crippling/Severe Restriction): Back pain broadly limits daily and social functioning, requiring active medical intervention.81%-100%: Individuals are either bed-bound or experiencing extreme symptom exaggeration.
Bubble Inclinometer
Time frame: upto 4 weeks
A bubble inclinometer is a simple, handheld device used to measure the angle of inclination or tilt of a surface. In the context of thoracic spine assessments, it is particularly useful for quantifying the range of motion and curvature of the spine.
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 28 Sep 2026.
- Background: PubMed 35343374Cibulka M, Buck J, Busta B, Neil E, Smith D, Triller R. Intra and inter observer agreement in the mobility assessment of the upper thoracic costovertebral joints. Physiother Theory Pract. 2023 Sep 2;39(9):1993-1999. doi: 10.1080/09593985.2022.2058439. Epub 2022 Mar 27.
- Background: PubMed 38172794Koivunen K, Widbom-Kolhanen S, Pernaa K, Arokoski J, Saltychev M. Reliability and validity of Oswestry Disability Index among patients undergoing lumbar spinal surgery. BMC Surg. 2024 Jan 3;24(1):13. doi: 10.1186/s12893-023-02307-w.
- BackgroundKirsten Elizabeth Petrie. E. K. (2019). Costovertebral Manipulation versus Ultrasound Therapy of Rhomboid Trigger Points and a Combination Thereof in Treating Inter-scapular Pain. PQDT-Global.
- Background: PubMed 32028982Honore M, Picchiottino M, Wedderkopp N, Leboeuf-Yde C, Gagey O. What is the effect of spinal manipulation on the pressure pain threshold in young, asymptomatic subjects? A randomized placebo-controlled trial, with a cross-over design. Chiropr Man Therap. 2020 Feb 7;28(1):6. doi: 10.1186/s12998-020-0296-1.
- Background: PubMed 30759118Masaracchio M, Kirker K, States R, Hanney WJ, Liu X, Kolber M. Thoracic spine manipulation for the management of mechanical neck pain: A systematic review and meta-analysis. PLoS One. 2019 Feb 13;14(2):e0211877. doi: 10.1371/journal.pone.0211877. eCollection 2019.
- Background: PubMed 29713457Honore M, Leboeuf-Yde C, Gagey O. The regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects: a systematic literature review. Chiropr Man Therap. 2018 Apr 19;26:11. doi: 10.1186/s12998-018-0181-3. eCollection 2018.
- Background: PubMed 36875686Tsegay GS, Gebregergs GB, Weleslassie GG, Hailemariam TT. Effectiveness of Thoracic Spine Manipulation on the Management of Neck Pain: A Systematic Review and Meta-Analysis of Randomized Control Trials. J Pain Res. 2023 Feb 27;16:597-609. doi: 10.2147/JPR.S368910. eCollection 2023.
- 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.
Samrood Akram, 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 facet manipulations, thoracic facet and costovertebral manipulations and Standard Physiotherapy 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 4 inclusion and 3 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 28 Sep 2026. 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?
Numerical Pain Rating Scale (NPRS) (time frame: upto 4 weeks). 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 NCT07063992, which also lists 7 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 28 Sep 2026.