Clinical trial NCT06299527: Telerehabilitation in Patients With Fibromyalgia
Official title: Clinical Outcomes of Asynchronous Telerehabilitation Are Equivalent to Synchronous Telerehabilitation in Patients With Fibromyalgia: a Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Telerehabilitation
Mobile health
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16).

Detailed description: Materials and methods: A randomized clinical study. Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16).

Eligibility criteria: Inclusion Criteria:

* Diagnosed with FMS by the physician in accordance with ACR 2016 criteria,
* Having independent mobility,
* Not having advanced vision and hearing loss,
* Minimum literacy, participating voluntarily, making video calls, Internet and smartphone access

Exclusion Criteria:

* Have a rheumatic disease with more prominent symptoms than FMS,
* Have an active infection,
* Have a surgical operation in the last three months,
* Have an uncontrollable chronic disease,
* Have another musculoskeletal disorder

Primary outcomes:
measure: Visual Analog Scale
timeFrame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Secondary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire
timeFrame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
measure: Pain Catastrophizing Scale
timeFrame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
measure: Hospital Anxiety and Depression Scale
timeFrame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
measure: 6 Minute Walk Test
timeFrame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
measure: Arm Curl Test
timeFrame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
measure: Laser Cursor Assisted Angle Repetition Test (LI-RATT)
timeFrame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
measure: Short Form - 12
timeFrame: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Faculty of Health Sciences
state: Maltepe
Study officials:
References:
citation: BALKE B. A SIMPLE FIELD TEST FOR THE ASSESSMENT OF PHYSICAL FITNESS. REP 63-6. Rep Civ Aeromed Res Inst US. 1963 Apr:1-8. No abstract available.
citation: Soylu C, Kütük B. "Reliability and validity study of the Turkish form of the SF-12 Quality of Life Scale." Turkish Journal of Psychiatry.2020; 1-9.
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
citation: Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychological assessment. 1995; 7(4): 524.
citation: Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10.