Chronic Musculoskeletal PainNCT07322822
Active Coping Program for Chronic Musculoskeletal Pain: A Controlled Clinical Study
A study testing Active Coping Program in people with Chronic Musculoskeletal Pain and Chronic Pain, run by Universidad de Extremadura at 1 site in Spain.
Trial summary
Chronic musculoskeletal pain is a highly prevalent condition that is often associated with persistent pain, physical disability, and maladaptive psychosocial factors such as pain catastrophizing, fear of movement, and central sensitization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain, Chronic Pain
- What is being tested?
- Active Coping Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2026to 1 Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Diagnosis of chronic musculoskeletal pain, defined as pain persisting for more than 3 months.
- Ability to understand study procedures and complete self-reported questionnaires.
- Ability to participate in an active coping program involving education and movement-based activities.
- Provision of written informed consent.
Who cannot join
- Presence of serious neurological, rheumatologic, or systemic disease that may interfere with participation in the intervention or outcome assessment.
- Severe cognitive impairment or psychiatric condition that limits understanding of the study procedures.
- Ongoing participation in another structured pain management or rehabilitation program.
- Any medical condition that, in the opinion of the investigators, would make participation unsafe or compromise study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Active Coping Program on Pain, Disability, and Psychosocial Factors in Patients With Chronic Musculoskeletal Pain: A Controlled Clinical Study
Chronic musculoskeletal pain is a highly prevalent condition that is often associated with persistent pain, physical disability, and maladaptive psychosocial factors such as pain catastrophizing, fear of movement, and central sensitization. These factors can contribute to pain persistence and reduced quality of life, highlighting the need for multimodal, non-pharmacological interventions that address both physical and psychological dimensions of pain.
The purpose of this study is to evaluate the effectiveness of an active coping program for patients with chronic musculoskeletal pain compared with usual care. The intervention is designed to promote active pain management strategies through education, movement-based exercises, and behavioral approaches aimed at improving pain coping, reducing disability, and addressing psychosocial contributors to chronic pain.
Read more
This is a controlled interventional study in which adult patients with chronic musculoskeletal pain will be allocated to either an intervention group receiving the active coping program or a control group receiving usual care. Outcome measures will be assessed at baseline and after completion of the intervention. Primary and secondary outcomes include pain-related disability, pain catastrophizing, fear of movement, symptoms of central sensitization, and health-related quality of life, measured using validated questionnaires.
The findings of this study are expected to provide evidence on the clinical effectiveness of an active coping approach in the management of chronic musculoskeletal pain and to support its implementation in routine clinical practice within primary care settings.
- Conditions
- Chronic Musculoskeletal Pain, Chronic Pain
- Being tested
- Active Coping Program, Usual Care
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Coping ProgramBehavioural
Participants assigned to this arm will receive an 8-week active coping program for chronic musculoskeletal pain. The program is a multimodal, non-pharmacological intervention aimed at improving self-management and active pain coping. Core components include pain education (e.g., understanding chronic pain mechanisms), movement-based therapeutic exercise/graded activity, and behavioral strategies to address maladaptive pain-related beliefs and behaviors (e.g., fear of movement and pain catastrophizing). The intervention is delivered following a standardized protocol to ensure consistency across participants.
Usual CareOther
Participants assigned to this arm will receive usual care as provided in routine clinical practice in primary care. No additional study-specific intervention is delivered. Usual care may include standard medical management, general advice and education, and referral to other services as clinically indicated, according to local practice.
| Study group | Role | What they receive |
|---|---|---|
| Active Coping Program | Experimental | Not described Receives: Behavioral: Active Coping Program |
| Usual Care | Active comparator | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a self-reported questionnaire assessing catastrophic thinking related to pain, including rumination, magnification, and helplessness.
The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing (worse outcome).
Measured: Baseline (Week 0) and post-intervention (Week 8)
Roland-Morris Disability Questionnaire (RMDQ)
The Roland-Morris Disability Questionnaire (RMDQ) is a self-reported questionnaire assessing pain-related physical disability in daily activities.
The total score ranges from 0 to 24, with higher scores indicating greater disability (worse outcome).
Measured: Baseline (Week 0) and post-intervention (Week 8)
Tampa Scale for Kinesiophobia (TSK-11)
The Tampa Scale for Kinesiophobia - 11 item version (TSK-11) is a self-reported questionnaire assessing fear of movement and re-injury related to pain.
Total scores range from 11 to 44, with higher scores indicating greater kinesiophobia (worse outcome).
Measured: Baseline (Week 0) and post-intervention (Week 8)
Central Sensitization Inventory (CSI)
The Central Sensitization Inventory (CSI) is a self-reported questionnaire used to assess symptoms associated with central sensitization.
The total score ranges from 0 to 100, with higher scores indicating greater symptom severity related to central sensitization (worse outcome).
Measured: Baseline (Week 0) and post-intervention (Week 8)
36-Item Short Form Health Survey (SF-36)
The 36-Item Short Form Health Survey (SF-36) is a generic self-reported questionnaire assessing health-related quality of life across multiple physical and mental health domains.
Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life (better outcome).
Measured: Baseline (Week 0) and post-intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Fernández-Morales, Universidad de Extremadura
- Investigators
- Luis Espejo-Antúnez, Ph.D., Study director, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322822
- Sponsor's protocol ID
- 11
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Active Coping Program on Pain, Disability, and Psychosocial Factors in Patients With Chronic Musculoskeletal Pain: A Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07322822
- Acronym / sponsor ID
- 11
- Conditions
- Chronic Musculoskeletal Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 7 Jan 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.
Chronic musculoskeletal pain is a highly prevalent condition that is often associated with persistent pain, physical disability, and maladaptive psychosocial factors such as pain catastrophizing, fear of movement, and central sensitization. These factors can contribute to pain persistence and reduced quality of life, highlighting the need for multimodal, non-pharmacological interventions that address both physical and psychological dimensions of pain.
The purpose of this study is to evaluate the effectiveness of an active coping program for patients with chronic musculoskeletal pain compared with usual care. The intervention is designed to promote active pain management strategies through education, movement-based exercises, and behavioral approaches aimed at improving pain coping, reducing disability, and addressing psychosocial contributors to chronic pain.
This is a controlled interventional study in which adult patients with chronic musculoskeletal pain will be allocated to either an intervention group receiving the active coping program or a control group receiving usual care. Outcome measures will be assessed at baseline and after completion of the intervention. Primary and secondary outcomes include pain-related disability, pain catastrophizing, fear of movement, symptoms of central sensitization, and health-related quality of life, measured using validated questionnaires.
The findings of this study are expected to provide evidence on the clinical effectiveness of an active coping approach in the management of chronic musculoskeletal pain and to support its implementation in routine clinical practice within primary care settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Coping Program | Experimental | Behavioral: Active Coping Program |
| Usual Care | Active comparator | Other: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Diagnosis of chronic musculoskeletal pain, defined as pain persisting for more than 3 months.
- Ability to understand study procedures and complete self-reported questionnaires.
- Ability to participate in an active coping program involving education and movement-based activities.
- Provision of written informed consent.
Key exclusion criteria (4 listed)
- Presence of serious neurological, rheumatologic, or systemic disease that may interfere with participation in the intervention or outcome assessment.
- Severe cognitive impairment or psychiatric condition that limits understanding of the study procedures.
- Ongoing participation in another structured pain management or rehabilitation program.
- Any medical condition that, in the opinion of the investigators, would make participation unsafe or compromise study results.
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 |
|---|---|---|
| Active Coping ProgramParticipants assigned to this arm will receive an 8-week active coping program for chronic musculoskeletal pain. The program is a multimodal, non-pharmacological intervention aimed at improving self-management and active pain coping. Core components include pain education (e.g., understanding chronic pain mechanisms), movement-based therapeutic exercise/graded activity, and behavioral strategies to address maladaptive pain-related beliefs and behaviors (e.g., fear of movement and pain catastrophizing). The intervention is delivered following a standardized protocol to ensure consistency across participants. | Behavioural | Active Coping Program |
| Usual CareParticipants assigned to this arm will receive usual care as provided in routine clinical practice in primary care. No additional study-specific intervention is delivered. Usual care may include standard medical management, general advice and education, and referral to other services as clinically indicated, according to local practice. | Other | Usual Care |
Primary outcome
Pain Catastrophizing Scale (PCS)
Time frame: Baseline (Week 0) and post-intervention (Week 8)
The Pain Catastrophizing Scale (PCS) is a self-reported questionnaire assessing catastrophic thinking related to pain, including rumination, magnification, and helplessness. The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing (worse outcome).
Roland-Morris Disability Questionnaire (RMDQ)
Time frame: Baseline (Week 0) and post-intervention (Week 8)
The Roland-Morris Disability Questionnaire (RMDQ) is a self-reported questionnaire assessing pain-related physical disability in daily activities. The total score ranges from 0 to 24, with higher scores indicating greater disability (worse outcome).
Tampa Scale for Kinesiophobia (TSK-11)
Time frame: Baseline (Week 0) and post-intervention (Week 8)
The Tampa Scale for Kinesiophobia - 11 item version (TSK-11) is a self-reported questionnaire assessing fear of movement and re-injury related to pain. Total scores range from 11 to 44, with higher scores indicating greater kinesiophobia (worse outcome).
Central Sensitization Inventory (CSI)
Time frame: Baseline (Week 0) and post-intervention (Week 8)
The Central Sensitization Inventory (CSI) is a self-reported questionnaire used to assess symptoms associated with central sensitization. The total score ranges from 0 to 100, with higher scores indicating greater symptom severity related to central sensitization (worse outcome).
36-Item Short Form Health Survey (SF-36)
Time frame: Baseline (Week 0) and post-intervention (Week 8)
The 36-Item Short Form Health Survey (SF-36) is a generic self-reported questionnaire assessing health-related quality of life across multiple physical and mental health domains. Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life (better outcome).
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 29 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Musculoskeletal Pain
Recruiting
Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease, Including Validation of AE-FS
Rheumatic Diseases, Pain, Chronic
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
Active, not recruitingPhase 3
Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia
Breast Cancer, Arthralgia
Not yet recruiting
Genicular Nerve Radiofrequency Ablation Versus Hyaluronic Acid Injection for Knee Osteoarthritis Pain
Knee Osteoarthritis, Chronic Knee Pain
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis
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.
Luis Espejo-Antúnez, Ph.D. study director
University of Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Coping Program in people with Chronic Musculoskeletal Pain and Chronic Pain, run by Universidad de Extremadura at 1 site in Spain.
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 5 inclusion and 4 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 29 Apr 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 Spain. 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?
Pain Catastrophizing Scale (PCS) (time frame: Baseline (Week 0) and post-intervention (Week 8)). The study lists 5 primary outcomes in all. 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 29 Apr 2026.