NCT07287696

Brief Summary

The purpose of this study was to compare between the effects of Siwan sand therapy and physical therapy program on pulmonary function, functional activity, and pain in rheumatoid arthritis patients. Forty five patients were recruited according to the American Rheumatism Association criteria 2010 for the study, fifteen of them had been dropped, the other thirty patients (11 male and 19 female) were assigned into two equal groups: group (A) received Siwan sand therapy inform of sand bath for 5-days, followed by massage with olive oil, while group (B) received physiotherapy for 2-months in form of hot back, TENS, aerobic exercise and strengthening exercise, for the period between June 2016 and August 2019. All patients were evaluated pre-treatment and post treatment

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

3.2 years

First QC Date

May 19, 2025

Last Update Submit

December 3, 2025

Conditions

Keywords

siwa,traditional therapy ,rheumatoid arthritis,pulmonary function

Outcome Measures

Primary Outcomes (1)

  • Pulmonary function

    Measured by spirometer, pulmonary function test performed for both group before and immediately after intervention, FVC was measured by asking the patient to take deep inspiration and then forcefully expire the air in the mouth piece of spirometer as fast as he could. FEV1 volume of air measured in the first second of forced expiration.

    2 year

Secondary Outcomes (2)

  • Functional disability

    2 year

  • pain severity

    2 year

Interventions

Patients received sand bathing between 2 pm and 4 pm between the end of May and the first two weeks of September. The atmospheric temperature was 40-45°C, the sand surface temperature ranged from 75 to 82°C and the temperature under the sand surface by 10-20 cm was 50-60°C, measured by an infrared thermometer (Medisana, Germany). A hole of 20-40 cm in depth, 80 cm in width and 100-150 cm in length was dug. A long shallow hole was dug in the early morning to permit the heating of the sand by the sun's rays; after the lying down the patient, he/she was covered to the neck by hot dry sand from the surface of the desert.

physical therapy program composed of aerobic and strengthening exercise, TENS and hot application 2 sessions per week for 2 months. Group (B): consisted of 15 patients who were treated by the Siwan traditional program consisting of 5-sessions of sand therapy for 5 days followed by massage with olive oil. Physiotherapy Aerobic exercises in the form of walking on a treadmill, with moderate intensity ranged from 55-65% of target heart rate, according to Karvonen formula {resting heart rate + (maximum heart rate - resting hart rate)55-65%}\[33\]; the patient performed intermittent aerobic exercise for 15-30 min at the first session; they began with 15 min walking and then the duration was increased to reach 30 min; patients began with warming up for 5-minutes, followed by stimulus phase for 5-20 minutes and ended with cooling down for 5-minutes. The patient performed walking as a home program for Two times per week. Moreover, the physiotherapy program involved progressive strengthen

Eligibility Criteria

Age25 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients were on their stable doses of anti-rheumatic drugs
  • Patients with moderate, severe rheumatoid arthritis
  • they had positive RF and anti-CCP
  • Both sexes participated in this study
  • their ages range from 25 to 59 years
  • body mass index from 25 to 30
  • Pain of at least 3 mm on a visual analogue scale (VAS) from 0 mm (no pain) to 10 mm (worst imaginable pain)
  • Patients with (I) complete functional capacity with ability to carry out all usual duties without handicaps, (II) functional capacity adequate to conduct normal activities despite handicap of discomfort or limited mobility of one or more joints, (III) functional capacity adequate to perform only a few or none of the duties of usual occupation or of self-care -

You may not qualify if:

  • uncontrolled arterial hypertension \[systolic blood pressure (SBP) ≥ 180 mm Hg and/or diastolic blood pressure (DBP) ≥ 100 mm Hg\] 32 (Tanaka and Kazumi, 1990).
  • Uncontrolled diabetes,
  • Previous renal transplanted patients,
  • Patients had coronary artery disease including: unstable angina,
  • Pregnant woman's,
  • Bleeding disorder,
  • Largely or wholly incapacitated with patient bedridden or wheel chair bound, permitting little or no self-care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a prospective, randomized, single blind, pre and post-test, clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 19, 2025

First Posted

December 17, 2025

Study Start

June 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations