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Not yet recruiting NCT07063992

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

No phase Interventional Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: thoracic facet manipulations, thoracic facet and costovertebral manipulations.
Who it may be relevant to
Registry conditions: Back Pain. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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
  • 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

Primary outcome measures

  • Numerical Pain Rating Scale (NPRS) [Time frame: upto 4 weeks]
  • Oswestry Disability Index [Time frame: upto 4 weeks]
  • Bubble Inclinometer [Time frame: upto 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Sehat Medical Complex — Lahore

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. PMID 35343374
  • 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. PMID 38172794
  • 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.
  • 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. PMID 32028982
  • 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. PMID 30759118
  • 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. PMID 29713457
  • 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. PMID 36875686

Identifiers

NCT: NCT07063992 · REC/RCR &AHS/24/0142 Alishah

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗