Effects of Thoracic Spine Manipulation With and Without Costovertebral Joint Manipulation in Patients Mid-back Pain

NCT ID: NCT07063992

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2025-10-31

Brief Summary

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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

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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

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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thoracic facet manipulations

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

Group Type EXPERIMENTAL

thoracic facet manipulations

Intervention Type OTHER

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 manipulationThese 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

thoracic facet and costovertebral manipulations

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

Group Type EXPERIMENTAL

thoracic facet and costovertebral manipulations

Intervention Type OTHER

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

Interventions

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thoracic facet manipulations

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 manipulationThese 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

Intervention Type OTHER

thoracic facet and costovertebral manipulations

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samrood Akram, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Sehat Medical Complex

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Samrood Akram, PhD Scholar

Role: CONTACT

03324806143

Alishah Malik, MSPT

Role: CONTACT

03064500637

Facility Contacts

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Waseem Javaid, PhD Scholar

Role: primary

03457881133

References

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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.

Reference Type BACKGROUND
PMID: 35343374 (View on PubMed)

Koivunen 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.

Reference Type BACKGROUND
PMID: 38172794 (View on PubMed)

Kirsten 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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 32028982 (View on PubMed)

Masaracchio 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.

Reference Type BACKGROUND
PMID: 30759118 (View on PubMed)

Honore 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.

Reference Type BACKGROUND
PMID: 29713457 (View on PubMed)

Tsegay 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.

Reference Type BACKGROUND
PMID: 36875686 (View on PubMed)

Other Identifiers

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REC/RCR &AHS/24/0142 Alishah

Identifier Type: -

Identifier Source: org_study_id

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