NCT04842669

Brief Summary

The main aim of the current study is to investigate the effects of Low-level Laser Therapy on exercise-induced muscle damage of wrist flexors in untrained young adults. A randomized controlled trial will be conducted at Sargodha Medical College, University of Sargodha. The sample size calculated is 16. The participants will be divided into two equal group; 1) Interventional group (Low level laser therapy), 2) Control group (conventional) each having 8 participants. The study duration will be six months after approval from Research board. Blocked randomization sampling technique will be used. The subjects will be randomly assigned to any of the interventional or control group. Interventional group will further be allocated to prophylactic or therapeutic group. Only Un-trained young Adults, Aged 19-25 (under-graduate/college and university students) without gender discrimination will be included in the study. Tools used in the study will be TALAG Scale (Soreness assessment), Goniometer (ROM), Algometer (Pressure¬-pain Threshold), Electronic digital hand Dynamometer (Grip Strength) and PRS (Perceived Recovery Status Scale). Data will be collected at baseline, 1hr, 24hr, 72hr, 96hr, 120hr, 148hr, 168hr and 192 hrs after the induction protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

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

October 20, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2021

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

April 10, 2021

Last Update Submit

September 24, 2021

Conditions

Keywords

exercise induced muscle damagewrist flexorlow level laser therapy

Outcome Measures

Primary Outcomes (5)

  • Numeric pain rating scale (NPRS):

    The Numeric Rating Scale is an 11 point scale where the end points are the extremes of no pain and pain as bad as it could be, or worst pain. Numerical Rating Scale has good sensitivity and generates data that can be statistically analyzed for audit purposes. Measurements were done at 24, 48, 72, 96,120, 144 and 168, and 192 hours at the same time of the day.

    8th day (192 hours)

  • TALAG Scale (Soreness assessment):

    TALAG scale will be used to assess the perceived soreness. It consists of points 1-7 on scale. The minimum level 1 with no pain and a maximum point 7 with unbearably painful.Measurement of all dependent variables at 24, 48, 72, 96,120, 144 and 168, and 192 hours after eccentric exercise were taken at the same time of the day.

    8th day (192 hours)

  • Goniometer

    Physical therapists widely use goniometer for measurement of different joint ranges to evaluate any ROM limitation. The universal full circle goniometer is the preferred instrument for measuring ROM.Measurement of all dependent variables at 24, 48, 72, 96,120, 144 and 168, and 192 hours after eccentric exercise were taken at the same time of the day.

    8th day (192 hours)

  • Pressure-pain Threshold by Algometer

    Algometer is a reliable tool for measuring pressure pain threshold(22).The Pressure Pain Threshold will be evaluated using an analogue algometer (Baseline, 60 pounds capacity) by applying vertical pressure. To stimulate the participant's pain, the pressure will be increased at a rate of 1kg/cm2.Measurements will be taken pre and post treatment for 2 times during study. Measurement of all dependent variables at 24, 48, 72, 96,120, 144 and 168, and 192 hours after eccentric exercise were taken at the same time of the day.

    8th day (192 hours)

  • Electronic digital hand Dynamometer

    Grip strength will be evaluated with an electronic digital hand dynamometer as per recommendations. Measurement of all dependent variables at 24, 48, 72, 96,120, 144 and 168, and 192 hours after eccentric exercise were taken at the same time of the day.

    8th day (192 hours)

Secondary Outcomes (1)

  • Perceived Recovery (Perceived Recovery Status Scale):

    8th day (192 hours)

Study Arms (2)

Low level laser therapy

EXPERIMENTAL

Low level laser therapy

Other: low level laser therapy

Conservative treatment

ACTIVE COMPARATOR

Conservative treatment

Other: Conservative treatment

Interventions

Endo-laser 422 with interchangeable laser probes will be used for the purpose. It is a 2-channel unit and is software operated. For treatment of small surfaces with mono laser there are diodes of 25, 100 and 500 milliWatt.Frequency will be adjusted to 500 Hz, dose 0.1/cm2 with time duration of 1-5 minutes.

Low level laser therapy

(Topical ibuprofen gel) for muscle soreness will be provided

Conservative treatment

Eligibility Criteria

Age19 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Un-trained young Adults

You may not qualify if:

  • Any Trauma
  • Any psychological condition
  • Participation in any scheduled Physical training
  • Athlete population
  • Use of any nutritional supplement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sargodha Medical College (University of Sargodha)

Sargodha, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Wrist Injuries

Interventions

Low-Level Light TherapyConservative Treatment

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Maria Khalid, MSOMPT

    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

April 10, 2021

First Posted

April 13, 2021

Study Start

October 20, 2020

Primary Completion

April 20, 2021

Study Completion

August 17, 2021

Last Updated

September 30, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations