NCT05415813

Brief Summary

the aim of the study is to check the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius. In previous studies, Muscle Energy Technique and Ischemic Compression are compared with different conventional and combined therapy approaches, including most of the techniques used to treat Trigger Points in the upper trapezius. No study has evaluated the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius. The outcome measures are a Numeric pain rating scale, universal goniometer and neck disability index questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

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

Study Start

First participant enrolled

August 17, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2022

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

June 8, 2022

Last Update Submit

April 6, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline in pain on Numeric Pain Rating Scale at week 4

    on a scale of 1 to 10, o means no pain while 10 means worst pain

    Baseline and week 4

  • Change from Baseline in Goniometer readings at week 4

    for flexion any value less than 90 degrees indicates limited range of motion, for extension any value less than 70 indicates limited range of motion, for lateral flexion values less than 20 and greater than 45 considered limited, for rotation value less than 90 is considered limited

    Baseline and week 4

  • Change from baseline in Neck disability index questionnaire scores at week 4

    on a scale of 0 to 50, 0 indicates no disability and 50 indicates completely disabled

    Baseline and week 4

Secondary Outcomes (3)

  • Pain on Numeric Pain Rating Scale at week 2

    week 2

  • Goniometer readings at week 2

    week 2

  • Neck disability index questionnaire scores at week 2

    week 2

Study Arms (2)

Ischemic Compression

ACTIVE COMPARATOR

Ischemic Compression will be applied to the upper trapezius trigger points in patients recruited in group 1.

Other: Ischemic Compression

Ischemic compression and Muscle Energy Technique

EXPERIMENTAL

ischemic compression along with muscle energy technique will be applied to the upper trapezius trigger points in patients allocated to group 2.

Other: Ischemic compression with Muscle Energy Technique

Interventions

It includes conventional Physical therapy, hot packs (75°C) for 20 minutes, and active stretching exercises for the upper trapezius muscle (slow, 5 repetitions per session, 10-second hold, and 10-second relaxation between two repetitions) as a baseline treatment. For the Ischemic compression, the patient will be in the supine position with the cervical spine in opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were kept in a lengthened position physiotherapist will apply gradually increasing pressure to the Trigger points until the subject perceived the first noticeable pain. At that moment, the pressure will be maintained until the discomfort and/or pain eased by around 50% as perceived by the patient, at which time the pressure will be increased until the discomfort appears again. This process will be maintained for 90 seconds.

Ischemic Compression

The Participants will receive all the treatments given to the active comparator group and they will also receive the Muscle Energy Technique treatment in supine position and the practitioner will stabilize the shoulder of the affected side with one hand, while the ear/mastoid area of the affected side will be held by the opposite hand. The head and neck were then bent towards the contralateral side, flexed, and ipsilaterally rotated. The subjects will then shrug the stabilized shoulder towards the ear at a sub-maximal pain-free effort (20% of the available strength). The isometric contraction will be held for 7-10s. This position will be maintained for 30 seconds and repeated three to five times per treatment session. Treatment sessions will be given on alternate days.

Ischemic compression and Muscle Energy Technique

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both gender Aged 18 to 50 years (40)
  • Participants with active myofascial trigger points in the upper trapezius diagnosed by a senior physiotherapist on the basis of Travel and Simon criteria will be randomly allocated into two clinical groups.
  • Taut band having palpable nodule within upper trapezius muscle
  • Pain produced in a specific pattern which is radiating in character when firm pressure is applied on trigger points

You may not qualify if:

  • Trauma (whiplash injury)
  • Injury to Cervical Spine
  • Cervical Spine surgery
  • Cervical Myelopathy and Radiculopathy
  • Osteoporosis of the cervical spine
  • Cervical myeloma
  • Complex regional pain syndrome
  • Patients with the H/O any Neurological, Rheumatology and other serious medical illnesses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sialkot

Sialkot, Punjab Province, Pakistan

Location

MeSH Terms

Interventions

Acupressure

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Syeda Khadija Kazmi, DPT

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 13, 2022

Study Start

August 17, 2021

Primary Completion

June 17, 2022

Study Completion

June 23, 2022

Last Updated

April 7, 2023

Record last verified: 2023-04

Locations