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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05779748
Other study ID # BIS-23-00007-11012023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 11, 2023
Est. completion date August 5, 2023

Study information

Verified date June 2024
Source Taif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this interventional study is to investigate the effectiveness of an acute bout of exercises on pain sensitivity and clinical pain among adults with Chronic Low Back Pain. The following question will be answered in this research Q1: Is acute bout of exercise effective in reducing pain among adults with Chronic Low Back Pain? Participants who agree to participate and sign the informed consent will be randomized to one of three groups: Group 1: Isometric exercise with neutral language and no verbal suggestion consisting of 1 rep of wall squat, 3 min or to volitional fatigue at 100° knee angle;(n=30). Group 2: Isometric exercise with neutral language and no verbal suggestion consisting of 3 reps of wall squat, 3 min or to volitional fatigue at 100°degree knee angle, 30-sec rest between rep, ;(n=30). Group 3 (Control group): true control (do nothing);(n=30).


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date August 5, 2023
Est. primary completion date June 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. aged 18 years or older; and 2. diagnosed with chronic non-specific LBP (lasting for more than 12 weeks). 3. Able to perform physical therapy exercises. Exclusion Criteria: 1. pregnancy. 2. patients who have neurological compromise (e.g., cauda equine syndrome or spinal nerve compromise). 3. Patients who have spinal pathologies (e.g., fracture, ankylosing spondylitis) 4. Uncontrolled diabetic. 5. who has any history of heart disease (e.g., myocardial infarction, embolism) 6. Orthopaedic impairment (e.g., balance problems)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Single bout of exercise
isometric wall squat at a knee joint angle of 100 degrees. Instruct participant to place their back against the wall with feet positioned parallel and spaced shoulder-width apart. Lower themselves down until they reached a knee joint angle of 100 degrees. Measure knee joint angle by placing a goniometer on the lateral epicondyle of the knee, in line with the femur whilst the anchor arm was in line with the lateral malleolus.

Locations

Country Name City State
Saudi Arabia King Abdullah Hospital Bisha

Sponsors (2)

Lead Sponsor Collaborator
Taif University King Abdullah Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain pressure threshold The pain will be measured using digital pressure algometer, FDX®? (Wagner instrument, Greenwich, USA). All trials will be conducted on forearm, lumbar spine and calf sites. There will be at least 20 sec rest before an individual site is tested again. Two trials will be performed at each site. The raw values of each test will be recorded.
Because we are testing repeated times, we will use a marker to mark the location of each test site to ensure consistency in location.
Algometer must be positioned perpendicular to the measurement site for all trials.
[ Time Frame: Change from pre-intervention (baseline) compared to post-intervention (immediately after session) ]
Primary Pain intensity It will be measured using Visual Analogue Scale (VAS; 0-10). A rating of zero means that participant don't currently have pain at the low back. A rating of ten on this scale means that the pain at low back is the worst pain. So, the higher the number on this scale means the higher the pain intensity participant is experiencing. [ Time Frame: Change from pre-intervention (baseline) compared to post-intervention (immediately after session) ]
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