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Multiple SclerosisJPMRTNCT07854691

Jacobson's Progressive Muscle Relaxation for Fatigue and Kinesiophobia in Multiple Sclerosis

A study testing Jacobson's Progressive Muscle Relaxation Technique (JPMRT) and Routine Care in people with Multiple Sclerosis, run by Al-Zaytoonah University of Jordan at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multiple sclerosis (MS) is a chronic neurological condition that can cause fatigue and fear of movement (kinesiophobia), which may interfere with daily activities and participation in rehabilitation. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Jacobson's Progressive Muscle Relaxation Technique (JPMRT) and Routine Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteEgypt
Study dates
1 Aug 2025to 30 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 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participants were eligible if they had a diagnosis of multiple sclerosis for at least six months, were aged 20-60 years, and were able to communicate and comprehend the study instructions.

Who cannot join

  • Patients with a documented psychotic disorder that could impair their ability to understand the study instructions, those who had received psychotherapy during the previous six months, or those who had participated in any program targeting physical health and/or fatigue during the previous six months were excluded.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Menoufia university

    Cairo, Menoufia Governorate

Other trials in Egypt

About this study

Official title: Changes in Fatigue and Kinesiophobia Following Jacobson's Progressive Muscle Relaxation Technique Among Patients With Multiple Sclerosis: A Quasi-Experimental Study

Multiple sclerosis (MS) is a chronic neurological condition that can cause fatigue and fear of movement (kinesiophobia), which may interfere with daily activities and participation in rehabilitation. Jacobson's Progressive Muscle Relaxation Technique (JPMRT) is a structured relaxation technique involving the sequential contraction and relaxation of different muscle groups.

This study examined the association between participation in an eight-week JPMRT program and changes in fatigue impact and kinesiophobia among patients with MS. A quasi-experimental, two-group pretest-posttest design was conducted at the Neurological Clinic and Neurological Department of Menoufia University Hospital, Egypt.

Read more

A total of 70 patients with MS participated in the study. Thirty-five patients were assigned to the control group and 35 to the JPMRT study group using a non-random sequential allocation procedure. The control group was recruited and assessed first, followed by recruitment and intervention of the study group, to reduce the possibility of sharing intervention-related information between participants.

Patients in the study group received a structured JPMRT program over eight weeks. The program included four supervised sessions during the first two weeks, followed by six weeks of daily home practice. Each supervised session lasted approximately 30-45 minutes. Participants were taught the correct sequence of contracting and relaxing major muscle groups through demonstration, redemonstration, feedback, educational materials, and instructions for home practice. Home practice was performed once daily for 10-15 minutes. The control group continued to receive routine neurological care without the JPMRT program during the study period.

Fatigue impact and kinesiophobia were assessed before and after the eight-week study period using the Modified Fatigue Impact Scale (MFIS) and the Tampa Scale of Kinesiophobia (TSK), respectively. Performance of the relaxation technique was also assessed in the JPMRT group using a performance checklist.

The study examined changes in fatigue impact and kinesiophobia within and between the two groups and the relationship between these outcomes after the intervention. Because participants were not randomly allocated and the groups were recruited during different periods, the findings were interpreted as an association rather than definitive evidence of a causal effect of JPMRT.

Read the detailed description

This study was conducted to examine the association between participation in a structured JPMRT program and changes in fatigue impact and kinesiophobia among patients with MS. The study also examined improvement in participants' ability to correctly perform the relaxation technique and the relationship between fatigue impact and kinesiophobia following the intervention.

A quasi-experimental, two-group pretest-posttest design was used. The study was conducted at the Neurological Clinic and Neurological Department of Menoufia University Hospital, Menoufia, Egypt. Participants were recruited using a convenience sampling approach. Because JPMRT involved direct instruction, demonstration, supervised practice, and home practice, the investigators considered that concurrent recruitment could increase the possibility of contamination through communication between participants. Therefore, a non-random sequential allocation procedure was used. Participants in the control group were recruited and assessed first, followed by recruitment and intervention of participants in the study group.

The study included 70 eligible participants, with 35 participants in each group. All participants completed the study and the post-intervention assessment. No participants were lost to follow-up, withdrew from the study, or discontinued the intervention.

The JPMRT program was standardized to promote consistency in intervention delivery. The supervised component involved instruction regarding the concept and purpose of progressive muscle relaxation, demonstration of the technique, participant redemonstration, corrective feedback, and guided practice. Participants were trained to sequentially contract and relax major muscle groups while focusing on relaxation and breathing. Educational materials containing illustrated instructions and the essential steps of the technique were also provided to support independent practice.

The supervised training was conducted in small groups in a quiet, comfortable, and well-ventilated environment. The intervention was delivered according to a predetermined protocol developed by the researchers based on the original work of Jacobson. Research team members involved in intervention delivery were trained in the standardized protocol before the intervention began. To reduce potential assessment bias, outcome assessment was conducted by a researcher who was not involved in delivering the intervention.

After the supervised training period, participants in the JPMRT group continued practicing the technique independently at home. Home practice was supported through regular follow-up and reminders. Participants were encouraged to report difficulties with the technique and received clarification and support during the home-practice period. Adherence to home practice was monitored throughout the intervention.

Participants in the control group continued to receive routine neurological care, including their prescribed medical treatment and usual follow-up according to their clinical needs. They did not receive the JPMRT training or home-practice program during the study period. For ethical fairness, educational materials and instructions regarding JPMRT were provided to control-group participants after completion of the study and data collection.

Fatigue impact was assessed using the Modified Fatigue Impact Scale (MFIS), which evaluates the perceived impact of fatigue on physical, cognitive, and psychosocial functioning. Kinesiophobia was assessed using the Tampa Scale of Kinesiophobia (TSK), which measures fear of movement and related beliefs. The Arabic versions used in the study had previously undergone validation, and reliability was also assessed in the study population. Performance of JPMRT was assessed using a structured performance checklist among participants who received the intervention.

Assessments were conducted before the intervention and following completion of the intervention period. The same standardized procedures and outcome measures were used for the pre-intervention and post-intervention assessments. Participants were identified using coded study numbers to maintain confidentiality. The researcher responsible for outcome assessment was independent of intervention delivery and was blinded to participants' group allocation.

Data were analyzed using IBM SPSS Statistics version 26.0. Categorical variables were summarized using frequencies and percentages, while continuous variables were summarized using appropriate measures of central tendency and dispersion. Between-group comparisons and within-group pre-post comparisons were conducted using non-parametric statistical procedures because the primary outcomes did not meet the assumptions required for parametric analysis. Effect sizes were calculated to describe the magnitude of observed differences, and correlation analysis was used to examine the relationship between post-intervention kinesiophobia and fatigue impact.

The study was approved by the Research Ethics Committee of the Faculty of Nursing, Menoufia University (ERCNMA 1000/7/5/112/25) and by the relevant administrative authorities of Menoufia University Hospital. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki and its subsequent amendments. Written informed consent was obtained from all participants before enrollment. Participation was voluntary, and participants were informed of their right to withdraw without consequences to their medical care. Confidentiality and anonymity were maintained throughout the study.

The study was conducted prospectively but was not registered in a public clinical trials registry before participant recruitment. Consequently, no registration number or registration date was available at the time of the study.

An important methodological consideration was the non-random sequential allocation. Although this approach was selected to reduce potential contamination between groups, recruiting the groups during different periods may have introduced selection bias and temporal confounding. Differences in participant characteristics, clinical circumstances, healthcare processes, seasonal influences, medication or disease-related factors, and other contextual factors could not be completely excluded. Therefore, non-significant baseline differences were not interpreted as proof of complete equivalence between the groups.

The study was designed to provide preliminary evidence regarding the association between participation in JPMRT and changes in fatigue impact and kinesiophobia. The findings were interpreted in light of the quasi-experimental design, non-random allocation, single-center setting, relatively small sample, potential temporal and selection bias, and absence of long-term follow-up. Further randomized controlled studies with concurrent recruitment, appropriate randomization, larger and more diverse samples, and longer follow-up were identified as appropriate next steps for confirming and extending the findings.

Being tested
Jacobson's Progressive Muscle Relaxation Technique (JPMRT), Routine Care
Keywords
Multiple Sclerosis, Jacobson's Progressive Muscle Relaxation Technique, Kinesiophobia, Fatigue, Progressive Muscle Relaxation, Neurological Rehabilitation
Medical subject headings
Multiple Sclerosis, Kinesiophobia, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Jacobson's Progressive Muscle Relaxation Technique (JPMRT)Behavioural

    A structured 8-week Jacobson's Progressive Muscle Relaxation Technique (JPMRT) program. Participants received four supervised sessions over 2 weeks, with two sessions per week and each session lasting approximately 30-45 minutes. The program included instruction, demonstration, redemonstration, corrective feedback, and educational materials. Participants subsequently practiced JPMRT independently at home once daily for 10-15 minutes for 6 consecutive weeks. Adherence was supported through weekly telephone calls and WhatsApp reminders. The technique involved sequential contraction of major muscle groups for approximately 5-10 seconds followed by relaxation for 20-30 seconds while focusing on relaxation and deep breathing.

  • Routine CareOther

    Participants continued to receive routine care provided by the neurology clinic, including their prescribed medical treatment and usual follow-up according to their clinical needs. They did not receive Jacobson's Progressive Muscle Relaxation Technique (JPMRT) training or the associated home-practice program during the 8-week study period. After completion of the study and data collection, control-group participants were provided with educational materials and instructions regarding JPMRT.

Study groups in NCT07854691
Study groupRoleWhat they receive
Jacobson's Progressive Muscle Relaxation Technique (JPMRT) GroupExperimentalParticipants received a structured 8-week Jacobson's Progressive Muscle Relaxation Technique (JPMRT) program. The intervention consisted of four supervised sessions delivered over 2 weeks (two sessions per week), with each session lasting approximately 30-45 minutes. Participants were instructed to practice JPMRT independently at home once daily for 10-15 minutes for 6 consecutive weeks. The intervention included demonstration, redemonstration, corrective feedback, educational materials, and weekly telephone/WhatsApp follow-up to support adherence.
Receives: Behavioral: Jacobson's Progressive Muscle Relaxation Technique (JPMRT)
Routine Care Control GroupActive comparatorParticipants continued to receive routine care provided by the neurology clinic, including their prescribed medical treatment and usual follow-up according to their clinical needs. They did not receive JPMRT training or the home-practice program during the study period. After completion of the study and data collection, participants in the control group were provided with educational materials and instructions regarding JPMRT.
Receives: Other: Routine Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Kinesiophobia

    Kinesiophobia was assessed using the Tampa Scale of Kinesiophobia (TSK), a 17-item instrument measuring fear of movement and re-injury. Each item is scored from 1 (strongly disagree) to 4 (strongly agree), with total scores ranging from 17 to 68. Higher scores indicate greater kinesiophobia. Kinesiophobia was assessed at baseline and after completion of the 8-week intervention.

    Measured: Baseline (Week 0) to 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.

  1. First posted2 Oct 2026
  2. Study start1 Aug 2025
  3. Primary completion30 Dec 2025
  4. Study completion30 Dec 2025

Resources

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
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Model description
A two-group, non-randomized, parallel-assignment, pretest-posttest design in which participants were allocated sequentially to either a routine-care control group or a Jacobson's Progressive Muscle Relaxation Technique (JPMRT) intervention group. The control group was recruited and assessed first, followed by recruitment and intervention of the study group to minimize potential contamination between groups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07854691
Sponsor's protocol ID
ERCNMA 1000/7/5/112/25
Acronym
JPMRT
Status last verified
Oct 2026
First submitted
27 Sep 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Jacobson's Progressive Muscle Relaxation Technique (JPMRT) and Routine Care in people with Multiple Sclerosis, run by Al-Zaytoonah University of Jordan at 1 site in Egypt.

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 1 inclusion and 1 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 5 Oct 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 Egypt. 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 Kinesiophobia (time frame: Baseline (Week 0) to post-intervention (Week 8)). 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 5 Oct 2026.

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