NCT05249660

Brief Summary

Study will be randomized clinical trial. Data will be collected from non probability consecutive sampling technique. Total 30 participants from Ganga Ram Hospital and Care medical centre will be selected and randomly allocated to two different groups i.e Group A and Group B. . Group A will be treated by trigger point release. Group B will be treated by Instrument assisted soft tissue release. NPRS, GONIOMETRY, NDI will be used as outcome measuring tool before and after treatment. Data will be analyzed by using Statistical package for social sciences 25.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2022

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

February 4, 2022

Last Update Submit

November 24, 2022

Conditions

Keywords

Upper trapezius pain

Outcome Measures

Primary Outcomes (3)

  • Numeric pain rating scale

    Scale consists of 4 questions regarding actual pain level, zero indicates no pain and 10 indicates worst pain imaginable

    6 weeks

  • Goniometry

    Goniometer is used to measure the ranges of body joints.

    6 weeks

  • Neck disability index

    Scale consists of 10 sections,each section contains questions regarding head/ neck pain and some questions regarding the daily activities that we perform

    6 weks

Study Arms (2)

Soft tissue release technique

EXPERIMENTAL

Patient sat on a chair. The therapist stood behind the participant and held one hand over head as the support, with the thumb of the other hand scan to detect the painful area of the latent TP of the upper trapezius muscle along the fibers. Then, pressure was applied by the thumb and the participant was asked to simultaneously actively change the muscle from shorted position to elongated state (ipsilateral side flexion of the cervical to the opposite side). This technique was repeated 3-5 times per session, and each repetition was maintained for 40-60 s till release is felt, with a 15-second rest interval. Three times passive stretching of the upper trapezius muscle was also performed for 45 s for each side.

Other: Soft tissue release technique

Instrument assisted soft tissue mobilization

ACTIVE COMPARATOR

Patient lied prone; the treatment was applied for approximately 20-seconds in a direction parallel to the muscle fibers with the instrument at a 45º angle. Followed immediately by treating the muscles in a direction perpendicular to the muscle fibers with the instrument at a 45º angle for an additional 20-second, resulting in a total treatment time of approximately 40 s. This technique was applied 3-5 times per session with 20 s rest between each time. Three times passive stretching of the upper trapezius muscle was also performed for 45 s for each side.

Other: Comparator: Instrument assisted soft tissue mobilization

Interventions

Patient sat on a chair. The therapist stood behind the participant and held one hand over head as the support, with the thumb of the other hand scan to detect the painful area of the latent TP of the upper trapezius muscle along the fibers. Then, pressure was applied by the thumb and the participant was asked to simultaneously actively change the muscle from shorted position to elongated state (ipsilateral side flexion of the cervical to the opposite side). This technique was repeated 3-5 times per session, and each repetition was maintained for 40-60 s till release is felt, with a 15-second rest interval. Three times passive stretching of the upper trapezius muscle was also performed for 45 s for each side.

Soft tissue release technique

Patient lied prone; the treatment was applied for approximately 20-seconds in a direction parallel to the muscle fibers with the instrument at a 45º angle. Followed immediately by treating the muscles in a direction perpendicular to the muscle fibers with the instrument at a 45º angle for an additional 20-second, resulting in a total treatment time of approximately 40 s. This technique was applied 3-5 times per session with 20 s rest between each time. Three times passive stretching of the upper trapezius muscle was also performed for 45 s for each side.

Instrument assisted soft tissue mobilization

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with neck pain in the upper trapezius muscle
  • Tender nodule, constant pain, a jump sign during palpation will be included in this study

You may not qualify if:

  • Patients with Whiplash injury
  • History of neck/shoulder surgery
  • Cervical Radiculopathy
  • History of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ganga Ram Hospital and Care medical centre

Lahore, Punjab Province, 54000, Pakistan

Location

Study Officials

  • Muhammad Sanaullah, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 4, 2022

First Posted

February 22, 2022

Study Start

January 25, 2022

Primary Completion

July 13, 2022

Study Completion

July 13, 2022

Last Updated

November 28, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations