FibromyalgiaNCT07421609
Effectiveness of the Strain Counterstrain Technique in Women With Fibromyalgia Syndrome
A study testing Conservative Physiotherapy Program and Strain Counterstrain Therapy in people with Fibromyalgia and Physiotherapy, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fibromyalgia, Physiotherapy, Pain
- What is being tested?
- Conservative Physiotherapy Program and Strain Counterstrain Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Turgut Ozal Medical Center
Malatya, 4400
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia, Physiotherapy, Pain, Strain Counterstrain Technique
- Being tested
- Conservative Physiotherapy Program, Strain Counterstrain Therapy
- Keywords
- Fibromyalgia Syndrome, Pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative Physiotherapy ProgramOther
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 TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Strain Counterstrain Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after completion of the 3-week intervention period
Secondary outcomes (4)
Change in Fatigue Severity Score (Fatigue Severity Scale)
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.
Measured: Baseline and immediately after completion of the 3-week intervention period
Change in Depression Score (Beck Depression Inventory)
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.
Measured: Baseline and immediately after completion of the 3-week intervention period
Change in Anxiety Score (Beck Anxiety Inventory)
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.
Measured: Baseline and immediately after completion of the 3-week intervention period
Change in Fibromyalgia Impact Score (Fibromyalgia Impact Questionnaire)
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.
Measured: Baseline and immediately after completion of the 3-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start4 Oct 2024
- Primary completion12 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlker DEMİR, Inonu University
- Investigators
- Ilker DEMİR, PhD, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421609
- Sponsor's protocol ID
- 2024/127
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Strain Counterstrain Technique in Women With Fibromyalgia Syndrome: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07421609
- Acronym / sponsor ID
- 2024/127
- Conditions
- Fibromyalgia, Physiotherapy, Pain, Strain Counterstrain Technique
- Keywords
- Fibromyalgia Syndrome, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Conservative Physiotherapy ProgramParticipants 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. |
| Conservative Treatment Plus Strain Counterstrain Group | Experimental | Procedure: Strain Counterstrain TherapyParticipants 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative Physiotherapy ProgramThe 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. | Other | Conservative Treatment Group |
| Strain Counterstrain TherapyStrain 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. | Procedure or surgery | Conservative Treatment Plus Strain Counterstrain Group |
Primary outcome
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.
4 secondary outcomes
Change in Fatigue Severity Score (Fatigue Severity Scale)
Time frame: 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
Change in Anxiety Score (Beck Anxiety Inventory)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilker DEMİR, PhD principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative Physiotherapy Program and Strain Counterstrain Therapy in people with Fibromyalgia and Physiotherapy, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (Visual Analog Scale) (time frame: Baseline and immediately after completion of the 3-week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.