Effectiveness of the Strain Counterstrain Technique in Women With Fibromyalgia Syndrome

February 23, 2026 updated by: İlker DEMİR, Hasan Kalyoncu University

Effect of the Strain Counterstrain Technique in Women With Fibromyalgia Syndrome: A Randomised Controlled Trial

This study evaluates whether strain counterstrain therapy affects pain, fatigue, psychological status, and quality of life in women diagnosed with fibromyalgia. Participants are assigned to one of three groups: a control group, a conservative treatment group, or a conservative treatment plus strain counterstrain therapy group. Treatment sessions are conducted five days per week for three weeks. Outcomes are assessed before and after the intervention using validated measurement scales. The purpose is to compare changes among groups and determine the effects of adding strain counterstrain therapy to conservative treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, and functional limitations that may negatively affect psychological well-being and quality of life. Nonpharmacological approaches are commonly used in management and may support symptom control and functional improvement. Manual therapy techniques are among the interventions applied to address musculoskeletal symptoms.

This study is designed to investigate the effects of strain counterstrain therapy in individuals diagnosed with fibromyalgia. Participants are assigned to different intervention groups receiving either standard care alone or standard care combined with a manual therapy approach. The intervention is administered according to a structured treatment protocol over a defined study period. Outcome measures evaluate changes in pain, fatigue, psychological status, and quality of life using validated assessment instruments.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Malatya, Turkey (Türkiye), 4400
        • Inonu University Turgut Ozal Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female participants aged within the predefined study age range
  • Diagnosis of fibromyalgia according to established clinical criteria
  • Ability to participate in treatment sessions and assessments
  • Willingness to participate and provide informed consent

Exclusion Criteria:

  • Those in menopause or postmenstrual period,
  • Those with psychiatric, neurological and/or chronic progressive systemic disease,
  • Those with immunodeficiency,
  • Those with heart, kidney, or liver failure,
  • Those receiving any pharmacological treatment,
  • Those with health issues preventing participation in the treatment programmes,
  • Pregnant patients were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Participants in this group do not receive any therapeutic intervention during the study period and continue their usual daily activities. Outcome assessments are performed at baseline and after the study period for comparison with the intervention groups.
Active Comparator: Conservative Treatment Group
Participants in this group receive conservative treatment consisting of standard physiotherapy modalities administered five days per week for three weeks according to a structured treatment protocol. No strain counterstrain therapy is applied in this group.
Other: Conservative Physiotherapy Program
The conservative physiotherapy program consists of standard physical therapy modalities applied according to a structured treatment protocol. Sessions are conducted five days per week for three weeks and include routinely used physiotherapy approaches intended to support symptom management and functional improvement.
Experimental: Conservative Treatment Plus Strain Counterstrain Group
Participants in this group receive conservative treatment consisting of standard physiotherapy modalities administered five days per week for three weeks, together with strain counterstrain therapy applied according to a structured manual therapy protocol.
Procedure: Strain Counterstrain Therapy
Strain counterstrain therapy is a manual therapy technique applied by a trained therapist using passive positioning methods intended to reduce musculoskeletal tenderness and improve comfort. The intervention is administered according to a structured treatment protocol during scheduled sessions over the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity (Visual Analog Scale)
Time Frame: Baseline and immediately after completion of the 3-week intervention period
Pain intensity is assessed using the Visual Analog Scale (VAS), a validated measure consisting of a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants indicate their pain level on the scale, and change is calculated as the difference between pre-intervention and post-intervention scores.
Baseline and immediately after completion of the 3-week intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fatigue Severity Score (Fatigue Severity Scale)
Time Frame: Baseline and immediately after completion of the 3-week intervention period
Fatigue is assessed using the Fatigue Severity Scale (FSS), a validated self-report questionnaire used to evaluate the impact of fatigue on daily functioning. Scores are calculated according to the instrument instructions, with higher scores indicating greater fatigue severity. Change is calculated as the difference between pre-intervention and post-intervention scores.
Baseline and immediately after completion of the 3-week intervention period
Change in Depression Score (Beck Depression Inventory)
Time Frame: Baseline and immediately after completion of the 3-week intervention period
Depression is assessed using the Beck Depression Inventory, a validated self-report questionnaire used to measure the severity of depressive symptoms. Scores are calculated according to the instrument guidelines, with higher scores indicating greater depression severity. Change is calculated as the difference between pre-intervention and post-intervention scores.
Baseline and immediately after completion of the 3-week intervention period
Change in Anxiety Score (Beck Anxiety Inventory)
Time Frame: Baseline and immediately after completion of the 3-week intervention period
Anxiety is assessed using the Beck Anxiety Inventory, a validated self-report questionnaire used to measure the severity of anxiety symptoms. Scores are calculated according to the instrument guidelines, with higher scores indicating greater anxiety severity. Change is calculated as the difference between pre-intervention and post-intervention scores.
Baseline and immediately after completion of the 3-week intervention period
Change in Fibromyalgia Impact Score (Fibromyalgia Impact Questionnaire)
Time Frame: Baseline and immediately after completion of the 3-week intervention period
Fibromyalgia impact is assessed using the Fibromyalgia Impact Questionnaire, a validated instrument used to evaluate symptom severity, functional status, and overall impact of fibromyalgia on daily life. Scores are calculated according to the questionnaire instructions, with higher scores indicating greater disease impact. Change is calculated as the difference between pre-intervention and post-intervention scores.
Baseline and immediately after completion of the 3-week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasan Kalyoncu University

Investigators

  • Principal Investigator: Ilker DEMİR, PhD, Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2024

Primary Completion (Actual)

November 12, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is currently undecided whether individual participant data will be shared. Data sharing plans will be determined after study completion in accordance with institutional policies, ethical approvals, and participant consent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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