FibromyalgiaREFLEX-FMNCT07614945
Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia
A study testing Foot Reflexology, Conventional Physical Therapy and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Fibromyalgia, run by Cairo University at 1 site in Egypt.
Trial summary
This randomized controlled trial aims to investigate the effect of foot reflexology on pain and sleep disorders in Egyptian female patients with fibromyalgia. Sixty female participants aged 18 to 65 years diagnosed with fibromyalgia will be randomly assigned into two equal groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Foot Reflexology, Conventional Physical Therapy and Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Egyptian female participants aged 18 to 65 years
- Diagnosis of fibromyalgia according to American College of Rheumatology (ACR) criteria
- Moderate pain intensity
- Poor sleep quality
- Ability and willingness to provide written informed consent
Who cannot join
- Comorbid conditions affecting pain or sleep, including rheumatoid arthritis and related disorders
- Previous reflexology treatment within the previous 6 months
- Any medical condition preventing participation in physical therapy or reflexology intervention
- Refusal or inability to comply with study procedures and follow-up requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Dekernis General Hospital
Al Mansurah, Dakahlia Governorate, 35744
Ghada M Mohamed El-Hady Ismaeil, BSc, PT, +201005677669, 10722018823327@pg.cu.edu.eg
Ghada M Mohamed El-Hady Ismaeil, BSc, PT
About this study
Official title: The Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia: A Randomized Controlled Trial
This randomized controlled trial aims to investigate the effect of foot reflexology on pain and sleep disorders in Egyptian female patients with fibromyalgia. Sixty female participants aged 18 to 65 years diagnosed with fibromyalgia will be randomly assigned into two equal groups. The control group will receive conventional physical therapy, including aerobic exercise, resistance training, and transcutaneous electrical nerve stimulation (TENS), while the experimental group will receive the same treatment in addition to foot reflexology. Interventions will be delivered twice weekly for six weeks. Pain, sleep quality, psychological distress, and functional activity will be evaluated at baseline and after treatment using validated Arabic assessment tools and pressure pain threshold measurements. The study aims to determine whether reflexology provides additional benefits when combined with conventional physical therapy in women with fibromyalgia.
Read the detailed description
Fibromyalgia is a chronic disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and impaired quality of life. Women represent the majority of affected individuals, and many patients continue to experience persistent symptoms despite pharmacological treatment. Reflexology is a non-invasive complementary therapy involving pressure application to specific foot reflex zones and has been proposed as an adjunctive intervention for symptom management in fibromyalgia.
This study is a prospective single-blinded randomized controlled trial designed to evaluate the effect of reflexology on pain, sleep quality, psychological distress, and functional activity in female patients with fibromyalgia.
Sixty Egyptian female participants aged 18-65 years who meet fibromyalgia diagnostic criteria will be recruited and randomly allocated into two equal groups. The control group will receive conventional physical therapy consisting of aerobic exercise, resistance training, and transcutaneous electrical nerve stimulation (TENS). The experimental group will receive the same conventional physical therapy program in addition to foot reflexology.
Both groups will receive treatment twice weekly for six weeks. Outcome measures will be assessed at baseline and post-treatment and include pressure pain threshold using algometry, the Arabic Fibromyalgia Impact Questionnaire, Arabic Pittsburgh Sleep Quality Index, Arabic Hospital Anxiety and Depression Scale, and Arabic Short Form-36 Health Survey.
The study seeks to determine whether adding foot reflexology to conventional physical therapy improves pain, sleep quality, psychological status, and functional outcomes in women with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- Foot Reflexology, Conventional Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Fibromyalgia, Reflexology, Foot Reflexology, Chronic Pain, Sleep Disorders, Physical Therapy, TENS, Fibromyalgia Syndrome, Pain Management, Women Health, Complementary Therapy, Randomized Controlled Trial
- Medical subject headings
- Fibromyalgia, Chronic Pain, Sleep Wake Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot ReflexologyBehavioural
Foot reflexology will be delivered twice weekly for six weeks, with each session lasting 30 minutes. Moderate thumb and finger pressure will be applied bilaterally to standardized foot reflex zones associated with fibromyalgia symptom management.
Conventional Physical TherapyOther
Conventional physical therapy includes aerobic exercise, stretching, and low-load resistance training administered twice weekly for six weeks. Exercise programs will be individualized and progressively adjusted according to participant tolerance.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
High-frequency TENS will be administered twice weekly for six weeks using conventional settings for pain management in fibromyalgia participants.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants will receive conventional physical therapy including aerobic exercise, resistance training, stretching exercises, and transcutaneous electrical nerve stimulation (TENS) twice weekly for six weeks. Receives: Other: Conventional Physical Therapy; Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Experimental Group | Experimental | Participants will receive conventional physical therapy in addition to foot reflexology twice weekly for six weeks. Conventional physical therapy includes aerobic exercise, resistance training, stretching exercises, and transcutaneous electrical nerve stimulation (TENS). Foot reflexology sessions will be conducted for 30 minutes per session following standardized reflexology protocols. Receives: Behavioral: Foot Reflexology; Other: Conventional Physical Therapy; Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold (PPT)
Pressure pain threshold will be assessed using a digital pressure algometer at predefined tender points. Three measurements will be obtained and averaged for analysis. Higher values indicate reduced pain sensitivity.
Measured: Baseline and 6 weeks
Fibromyalgia Symptom Impact (FIQ-A)
Fibromyalgia symptom impact will be assessed using the Arabic version of the Fibromyalgia Impact Questionnaire (FIQ-A). Scores range from 0 to 100, with higher scores indicating greater disease impact and symptom burden.
Measured: Baseline and 6 weeks
Secondary outcomes (3)
Sleep Quality (PSQI-A)
Sleep quality will be assessed using the Arabic version of the Pittsburgh Sleep Quality Index (PSQI-A). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality and greater sleep disturbance.
Measured: Baseline and 6 weeks
Psychological Distress (HADS)
Psychological distress will be evaluated using the Arabic Hospital Anxiety and Depression Scale (HADS), including anxiety and depression subscales. Each subscale score ranges from 0 to 21 and the total score ranges from 0 to 42. Higher scores indicate greater psychological distress.
Measured: Baseline and 6 weeks
Functional Activity and Health-Related Quality of Life (SF-36v2)
Functional activity and health-related quality of life will be assessed using the Arabic version of the Short Form-36 Health Survey Version 2 (SF-36v2). Scores range from 0 to 100, with higher scores indicating better health status, physical functioning, and quality of life.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start3 Jun 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Two-arm parallel randomized controlled trial comparing conventional physical therapy alone versus conventional physical therapy combined with foot reflexology in female patients with fibromyalgia.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mahmoud Mohamed El-Hady Ismaeil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614945
- Sponsor's protocol ID
- FPT-CU-REFLEX-FM-2026
- Other IDs
- P.T.REC/012/006040
- Acronym
- REFLEX-FM
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akin Korhan E, Uyar M, Eyigor C, Yont GH, Khorshid L. Effects of Reflexology on Pain in Patients With Fibromyalgia. Holist Nurs Pract. 2016 Nov/Dec;30(6):351-359. doi: 10.1097/HNP.0000000000000178.
PubMed 27763930Lee J, Han M, Chung Y, Kim J, Choi J. Effects of foot reflexology on fatigue, sleep and pain: a systematic review and meta-analysis. J Korean Acad Nurs. 2011 Dec;41(6):821-33. doi: 10.4040/jkan.2011.41.6.821.
PubMed 22310867Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
PubMed 27916278
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07614945
- Acronym / sponsor ID
- REFLEX-FM / FPT-CU-REFLEX-FM-2026
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Reflexology, Foot Reflexology, Chronic Pain, Sleep Disorders, Physical Therapy, TENS, Fibromyalgia Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jun 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 29 May 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 randomized controlled trial aims to investigate the effect of foot reflexology on pain and sleep disorders in Egyptian female patients with fibromyalgia. Sixty female participants aged 18 to 65 years diagnosed with fibromyalgia will be randomly assigned into two equal groups. The control group will receive conventional physical therapy, including aerobic exercise, resistance training, and transcutaneous electrical nerve stimulation (TENS), while the experimental group will receive the same treatment in addition to foot reflexology. Interventions will be delivered twice weekly for six weeks. Pain, sleep quality, psychological distress, and functional activity will be evaluated at baseline and after treatment using validated Arabic assessment tools and pressure pain threshold measurements. The study aims to determine whether reflexology provides additional benefits when combined with conventional physical therapy in women with fibromyalgia.
Detailed description
Fibromyalgia is a chronic disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and impaired quality of life. Women represent the majority of affected individuals, and many patients continue to experience persistent symptoms despite pharmacological treatment. Reflexology is a non-invasive complementary therapy involving pressure application to specific foot reflex zones and has been proposed as an adjunctive intervention for symptom management in fibromyalgia.
This study is a prospective single-blinded randomized controlled trial designed to evaluate the effect of reflexology on pain, sleep quality, psychological distress, and functional activity in female patients with fibromyalgia.
Sixty Egyptian female participants aged 18-65 years who meet fibromyalgia diagnostic criteria will be recruited and randomly allocated into two equal groups. The control group will receive conventional physical therapy consisting of aerobic exercise, resistance training, and transcutaneous electrical nerve stimulation (TENS). The experimental group will receive the same conventional physical therapy program in addition to foot reflexology.
Both groups will receive treatment twice weekly for six weeks. Outcome measures will be assessed at baseline and post-treatment and include pressure pain threshold using algometry, the Arabic Fibromyalgia Impact Questionnaire, Arabic Pittsburgh Sleep Quality Index, Arabic Hospital Anxiety and Depression Scale, and Arabic Short Form-36 Health Survey.
The study seeks to determine whether adding foot reflexology to conventional physical therapy improves pain, sleep quality, psychological status, and functional outcomes in women with fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel randomized controlled trial comparing conventional physical therapy alone versus conventional physical therapy combined with foot reflexology in female patients with fibromyalgia.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional Physical Therapy, Device: Transcutaneous Electrical Nerve Stimulation (TENS)Participants will receive conventional physical therapy including aerobic exercise, resistance training, stretching exercises, and transcutaneous electrical nerve stimulation (TENS) twice weekly for six weeks. |
| Experimental Group | Experimental | Behavioral: Foot Reflexology, Other: Conventional Physical Therapy, Device: Transcutaneous Electrical Nerve Stimulation (TENS)Participants will receive conventional physical therapy in addition to foot reflexology twice weekly for six weeks. Conventional physical therapy includes aerobic exercise, resistance training, stretching exercises, and transcutaneous electrical nerve stimulation (TENS). Foot reflexology sessions will be conducted for 30 minutes per session following standardized reflexology protocols. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Egyptian female participants aged 18 to 65 years
- Diagnosis of fibromyalgia according to American College of Rheumatology (ACR) criteria
- Moderate pain intensity
- Poor sleep quality
- Ability and willingness to provide written informed consent
Key exclusion criteria (4 listed)
- Comorbid conditions affecting pain or sleep, including rheumatoid arthritis and related disorders
- Previous reflexology treatment within the previous 6 months
- Any medical condition preventing participation in physical therapy or reflexology intervention
- Refusal or inability to comply with study procedures and follow-up requirements
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 |
|---|---|---|
| Foot ReflexologyFoot reflexology will be delivered twice weekly for six weeks, with each session lasting 30 minutes. Moderate thumb and finger pressure will be applied bilaterally to standardized foot reflex zones associated with fibromyalgia symptom management. | Behavioural | Experimental Group |
| Conventional Physical TherapyConventional physical therapy includes aerobic exercise, stretching, and low-load resistance training administered twice weekly for six weeks. Exercise programs will be individualized and progressively adjusted according to participant tolerance. | Other | Control Group, Experimental Group |
| Transcutaneous Electrical Nerve Stimulation (TENS)High-frequency TENS will be administered twice weekly for six weeks using conventional settings for pain management in fibromyalgia participants. | Device | Control Group, Experimental Group |
Primary outcome
Pressure Pain Threshold (PPT)
Time frame: Baseline and 6 weeks
Pressure pain threshold will be assessed using a digital pressure algometer at predefined tender points. Three measurements will be obtained and averaged for analysis. Higher values indicate reduced pain sensitivity.
Fibromyalgia Symptom Impact (FIQ-A)
Time frame: Baseline and 6 weeks
Fibromyalgia symptom impact will be assessed using the Arabic version of the Fibromyalgia Impact Questionnaire (FIQ-A). Scores range from 0 to 100, with higher scores indicating greater disease impact and symptom burden.
3 secondary outcomes
Sleep Quality (PSQI-A)
Time frame: Baseline and 6 weeks
Psychological Distress (HADS)
Time frame: Baseline and 6 weeks
Functional Activity and Health-Related Quality of Life (SF-36v2)
Time frame: Baseline and 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 27763930Akin Korhan E, Uyar M, Eyigor C, Yont GH, Khorshid L. Effects of Reflexology on Pain in Patients With Fibromyalgia. Holist Nurs Pract. 2016 Nov/Dec;30(6):351-359. doi: 10.1097/HNP.0000000000000178.
- Background: PubMed 22310867Lee J, Han M, Chung Y, Kim J, Choi J. Effects of foot reflexology on fatigue, sleep and pain: a systematic review and meta-analysis. J Korean Acad Nurs. 2011 Dec;41(6):821-33. doi: 10.4040/jkan.2011.41.6.821.
- Background: PubMed 27916278Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Reflexology, Conventional Physical Therapy and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Fibromyalgia, run by Cairo University 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 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: looking for participants now, as of the sponsor's last update on 4 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghada M Mohamed El-Hady Ismaeil, BSc, PT (+201005677669, 10722018823327@pg.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold (PPT) (time frame: Baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07614945, which also lists 3 linked publications.
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 4 Jun 2026.