Effectiveness of the Strain Counterstrain Technique in Women With Fibromyalgia Syndrome

NCT07421609 | Completed

• 1 other identifier: 2024/127
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia; Physiotherapy; Pain; Strain Counterstrain Technique

Keywords

Fibromyalgia Syndrome; Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity (Visual Analog Scale)

  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 Outcomes (4)

• Change in Fatigue Severity Score (Fatigue Severity Scale)

  Baseline and immediately after completion of the 3-week intervention period

• Change in Depression Score (Beck Depression Inventory)

  Baseline and immediately after completion of the 3-week intervention period

• Change in Anxiety Score (Beck Anxiety Inventory)

  Baseline and immediately after completion of the 3-week intervention period

• Change in Fibromyalgia Impact Score (Fibromyalgia Impact Questionnaire)

  Baseline and immediately after completion of the 3-week intervention period

Study Arms (3)

Control Group

NO INTERVENTION

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.

Conservative Treatment Group

ACTIVE COMPARATOR

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

Conservative Treatment Plus Strain Counterstrain Group

EXPERIMENTAL

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

Interventions

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.

Conservative Treatment Group

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.

Conservative Treatment Plus Strain Counterstrain Group

Eligibility Criteria

• Gender Eligibility Details: Only individuals who identify as female are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Inonu University Turgut Ozal Medical Center

Malatya, 4400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ilker DEMİR, PhD

  Inonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are assigned to one of three parallel groups: a control group, a conservative treatment group, or a conservative treatment plus strain counterstrain therapy group. All groups are followed over the same study period, and outcomes are assessed before and after the intervention to compare changes among groups.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: October 4, 2024
• Primary Completion: November 12, 2025
• Study Completion: December 1, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

TU (1)