NCT06138860

Brief Summary

This study aims to investigate the impact of impact of strain counterstrain technique on pain, lumbar range of motion and functional impairment in patients with lower back Myofascial pain syndrome.

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 Dec 2023

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

November 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

November 11, 2023

Last Update Submit

March 3, 2024

Conditions

Keywords

Low back PainMyofascial pain syndromeStrain counter strain techniquetrigger point

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    A Visual Analogue Scale (VAS) will be used by the patient to mark his or her level of pain, usually 10 cm long, ranging from no pain or discomfort (zero) to the worst pain that the patient can possibly feel.

    up to four weeks

Secondary Outcomes (2)

  • range of motion assessment

    up to four weeks

  • functional impairment

    up to four weeks

Study Arms (2)

strain counter strain technique

EXPERIMENTAL

the patients will receive strain counter strain technique plus physical therapy exercises three times a week for four weeks

Other: strain counter strain techniqueOther: physical therapy exercises

physical therapy exercises

ACTIVE COMPARATOR

the patients will receive physical therapy exercise three times a week for four week

Other: physical therapy exercises

Interventions

It will be done in accordance with the technique principles in which the therapist will locate trigger point, and then find a position of comfort or mobile point (at least a 70% decrease in tenderness),monitored the tender point, holding the position o f comfort for 90 seconds, It will be conducted three times per session, for twelve sessions three times per week every other day over the course of a month.

strain counter strain technique

Physical therapy exercises for twelve sessions, three times a week, over the course of a month. Exercises will include: stretching exercises for the hamstring, calf muscles, and back muscles. strengthening exercises for back muscles and abdominal muscles.

physical therapy exercisesstrain counter strain technique

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patients age from 20 to 40 years for both genders.
  • Patients (office worker) with mechanical back pain for 3 months ago and has not been diagnose as a specific disease or spinal abnormality.
  • Patients suffering from active MTrPS in lower back muscle.
  • According to the Oswestry Low Back Pain Disability Questionnaire, patients suffered moderate disability care (20-40%).
  • Patients capable of doing ROM assessment of Lumbar Spine (flexion, extension, as well as side binding) within the limit of pain.

You may not qualify if:

  • Neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor.
  • Psychiatric/mental deficit.
  • Patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment.
  • Vertebral compression fracture
  • Pregnancy and lactation.
  • Existing lower limb symptoms.
  • Activity intolerance due to cardiopulmonary disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghada Mohamed Rashad Koura

Abhā, Saudi Arabia

Location

MeSH Terms

Conditions

Low Back PainMyofascial Pain Syndromes

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Ghada MR Koura, Ass. prof

    King Khalid University, Saudi Arabia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
random generator
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: strain counter strain technique and physical therapy exercises
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy for basic science department., faculty of physical Therapy

Study Record Dates

First Submitted

November 11, 2023

First Posted

November 18, 2023

Study Start

December 1, 2023

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations