NCT06556758

Brief Summary

Aim of this randomized controlled trial is to see the effects of stripping massage on rhomboids major and minor active trigger points in patients with upper thoracic pain for reducing pain, enhancing thoracic range of motion and physical functioning

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

August 13, 2024

Last Update Submit

August 13, 2024

Conditions

Keywords

Stripping massage, Upper thoracic pain, Active trigger points

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale NPRS

    The NPRS is a segmented numeric version of the visual analog scale which is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.

    4 weeks

Secondary Outcomes (1)

  • Bubble inclinometer

    4 weeks

Other Outcomes (1)

  • Functional rating index

    4 weeks

Study Arms (2)

stripping massage + conventional Therapy

EXPERIMENTAL

Stripping Massage Stripping massage on rhomboid major and minor active trigger point in the direction of muscle fiber from origin to insertion of muscle. Frequency: 3 minutes for 3 times/week for 4 consecutive weeks. Conventional therapy including Hot pack for 10 minutes + ischemic compression for 90 secs + CPA glides grade 3 kaltenborn mobilization on thoracic T1 to T4 (5 reps x 1 set) Frequency: 3 times/ week for 4 weeks

Other: stripping massage + conventional therapy

Conventional therapy

ACTIVE COMPARATOR

Conventional Therapy Conventional PT including Hot pack for 10 minutes + ischemic compression for 90 secs + CPA glides grade 3 kaltenborn mobilization on thoracic T1 to T4(5 reps x 1 set ) Frequency : 3 times/ week for 4 weeks

Other: Conventional therapy

Interventions

Stripping massage on rhomboid major and minor active trigger point in the direction of muscle fiber from origin to insertion of muscle. Frequency: 3 minutes for 3 times/week for 4 consecutive weeks. Conventional PT including Hot pack for 10 minutes + ischemic compression for 90 secs + CPA glides grade 3 kaltenborn mobilization on thoracic T1 to T4 (5 reps x 1 set) Frequency: 3 times/ week for 4 weeks

Also known as: Stripping massage on rhomboid major and minor active trigger points
stripping massage + conventional Therapy

conventional therapy including Hot pack for 10 minutes + ischemic compression for 90 secs + CPA glides grade 3 kaltenborn mobilization on thoracic T1 to T4 (5 reps x 1 set ) Frequency : 3 times/ week for 4 weeks

Conventional therapy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants falling in this category would be recruited into the study.
  • females
  • Age: 18-40
  • Active TrPs in the rhomboid major and minor muscles.
  • Presence of atleast one trigger point in rhomboids (diagnosed by the characteristics like hyperirritable spot in a taut band, twitch response and referral pain)
  • Presence of Jump sign
  • Segmental hypomobility in upper thoracic region identified with positive springing test
  • upper thoracic pain, defined as pain in the body region encompassing from T1 to T4) pain intensity score of ≥ 3 on the numeric pain rating scale (0-10)
  • symptoms provoked by thoracic movement,or palpation of the rhomboid muscles.

You may not qualify if:

  • Participants falling in this category would be excluded from the study.
  • a history of neck trauma
  • previously had surgery in the neck or shoulder area or suffered from physical injury
  • Fractures, Dislocations, Traumatic injuries, Adhesive capsulitis, thoracic outlet syndrome.
  • any rheumatic condition, osteoporosis, cancer, spinal infection, radicular pain, or neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Madiha Ali, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Aqsa Mustafa, MSompt*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madiha Ali, MS-OMPT

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 16, 2024

Study Start

August 9, 2024

Primary Completion

December 30, 2024

Study Completion

January 10, 2025

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations