NCT07063992

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 3, 2025

Last Update Submit

July 3, 2025

Conditions

Keywords

Craniovertebral AngleMid-Back Painmuscle strength

Outcome Measures

Primary Outcomes (3)

  • 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

    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.

    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.

    upto 4 weeks

Study Arms (2)

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

Other: thoracic facet manipulations

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

Other: thoracic facet and costovertebral manipulations

Interventions

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 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

thoracic facet and costovertebral manipulations

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Medical Complex

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (7)

  • 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: 35343374BACKGROUND
  • 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: 38172794BACKGROUND
  • 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.

    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.

    PMID: 32028982BACKGROUND
  • 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: 30759118BACKGROUND
  • 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: 29713457BACKGROUND
  • 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: 36875686BACKGROUND

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Samrood Akram, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samrood Akram, PhD Scholar

CONTACT

Alishah Malik, MSPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 14, 2025

Study Start

July 1, 2025

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations