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Clinical Trials/NCT07287696
NCT07287696CompletedNot Applicable

Effect of Siwan Sand Therapy on Pulmonary Functions of Rheumatoid Arthritis Patients

Ahram Canadian University2 sites in 1 country15 target enrollmentStarted: June 1, 2016Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
2
Primary Endpoint
Pulmonary function

Study Overview

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

Detailed Description

The study was designed as a prospective, randomized, single blind, pre and post-test, clinical trial. Approval of the Ethical Committee was obtained from the institutional review board at Faculty of physical therapy, Cairo University before study started. The study was followed the Guidelines of Declaration of Helsinki on the conduct of human research. The study was conducted for the period between June 2016 and August 2019.

Study participants A sample of forty five RA patients, from both gender. from Ekasr Eleiny hospital, and from other private clinic located in Cairo were recruited to participate in the study. They were interviewed individually to assess their eligibility to be included in the study. They were assessed and treated at Cairo University out patients clinic, private clinic and in Siwa oasis traditional healing center in Marsa Matrouh Governorate, pre and post pulmonary function test performed in fitness and rehabilitation unite in Elaser Elainy hospital.

The inclusion criteria were definite RA that fulfilled the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for RA [31], 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 [16].

Patients who were known to have one of the following criteria were excluded from the study: 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.

Randomization Fifteen patients had been dropped, two of them were misdiagnosed, one of them have disc prolapse that prevent here from traveling from Cairo to Siwa as it was a long distance, some of them refused to complete the physical therapy sessions as they felt that there was not any improvement in their cases, one of them had had depression and anxiety she refused to complete the sessions, some of them refused to perform pulmonary function test after sessions as they were afraid of transmission of infection. The other 30 (11 male and 19 female) patients were randomly assigned into two groups by a blinded and an independent research assistant who opened sealed envelopes that contained a computer generated randomization card. Written informed consent was obtained from all participants before the baseline evaluation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
25 Years to 59 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • The inclusion criteria were definite RA that fulfilled the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for RA
  • 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 -

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Pulmonary function

Time Frame: 2 year

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.

Secondary Outcomes

  • Functional disability(2 year)
  • pain severity(2 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nashwa Mohammed Alaa Allam

lecturer

Ahram Canadian University

Study Sites (2)

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