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NCT Number: NCT07421609

Effectiveness of the Strain Counterstrain Technique in Women With Fibromyalgia Syndrome

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Physiotherapy Rheumatic Diseases Signs and Symptoms Strain Counterstrain Technique

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University Turgut Ozal Medical Center

Malatya, 4400, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conservative Physiotherapy Program

Other

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.

Strain Counterstrain Therapy

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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