NCT05497856

Brief Summary

The aim of this research is to compare the effect of integrated neuromuscular inhibition technique and myofascial release on pain, pain pressure threshold and shoulder disability in patients with rhomboid muscle. Randomized controlled trials will be done at Benazir Bhutto Hospital. The sample size is 32. The subjects will be divided in two groups, 16 subjects in integrated neuromuscular inhibition technique group and 16 in myofascial release group. Study duration will be of 6 months. Sampling technique applied will be non-probability purposive sampling technique. Only 25-45 years patients with shoulder/mid back pain and the presence of atleast one trigger point in rhomboid muscles will be included. Tools used in the study are algometer, shoulder pain and disability index (SPADI) and Numeric pain rating scale (NPRS). Data will be analyzed through SPSS 21.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 10, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

1 month

First QC Date

August 10, 2022

Last Update Submit

November 8, 2022

Conditions

Keywords

pain pressure thresholdalgometerSPADI

Outcome Measures

Primary Outcomes (2)

  • NPRS

    it is a 11 point scale for pain measurements with 0 describing no pain and 10 describing max. pain. changes will be measure from baseline to 2nd week

    2nd week

  • Pain Pressure threshold

    Pain pressure threshold is measured using algometer. The term algometer may imply pressure tolerance testing, the maximum amount of pressure one may endure. The point at which subjects first said they felt pain was called the Verbal Report of Pain (VRP). The point at which they said the pressure 'hurt a lot' was called the Pain Reaction Point (PRP). changes will be measured from baseline to 2nd week

    2nd week

Secondary Outcomes (1)

  • shoulder pain and disability index (SPADI)

    2nd week

Study Arms (2)

Integrated neuromuscular inhibition technique

EXPERIMENTAL

ischemic compression, strain counter strain, muscle energy techniques

Other: Integrated neuromuscular inhibition technique

Myofascial Release

ACTIVE COMPARATOR

Deep sustained pressure on the trigger points

Other: Myofascial Release

Interventions

Ischemic compression will be applied for 90 seconds followed by the SCS technique with a reduction in pain of at least 70%. it will be held for 20-30 sec followed by the Muscle energy technique in which the isometric contraction will be held for 7-10 sec and then the stretch will be held for 30 sec. This will be repeated 5 times per session with a 30-second rest interval in between each repetition Session will be held 3 times per week for 2 consecutive weeks

Integrated neuromuscular inhibition technique

Deep sustained pressure on the trigger points will be applied with thumb in 5-7/10 pain tolerance and maintained for 60 seconds and then will be released in a vertical direction followed by stretch of the rhomboid muscle held for 30 sec. This Sustained manual pressure will be applied for 3 times each followed by a stretch per session with a 30 sec rest interval in between .Session will be held 3 times per week for 2 consecutive weeks.

Myofascial Release

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Shoulder or mid back pain
  • Presence of atleast one trigger points in rhomboids (diagnosed by the characteristics like hyperirritable spot in a taut band, twitch response and referral pain)
  • Presence of Jump sign

You may not qualify if:

  • Any history of recent shoulder or Neck surgeries
  • Fractures, Dislocations, Traumatic injuries, Adhesive capsulitis, Tendinitis, thoracic outlet syndrome, Advanced osteoporosis, Psychiatric Disorders
  • Signs of cervical spinal cord compromise (e.g. diffuse sensory abnormality, diffuse weakness, hyperreflexia, or the presence of clonus
  • Two or more signs of nerve root involvement (e.g. dermatomal sensation changes, myotomal weakness, or diminished/absent tendon jerk reflexes)
  • A history of shoulder degenerative joint disease as per radiographs, endocrine disorders, and autoimmune conditions (e.g. rheumatoid arthritis, fibromyalgia etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benazir Bhutto Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Aisha Razzaq, MSPT-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

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 10, 2022

First Posted

August 11, 2022

Study Start

August 10, 2022

Primary Completion

September 15, 2022

Study Completion

September 30, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations