The Effect of an Acute Bout of Exercise on Pain Sensitivity and Clinical Pain in Adults With Chronic Low Back Pain

NCT05779748 | Completed

• 1 other identifier: BIS-23-00007-11012023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to investigate the efficacy of an acute bout of exercises on pain sensitivity (primary aim) and clinical pain intensity (secondary aim) 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).

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

• 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) ]

Secondary Outcomes (1)

• Pain intensity

  [ Time Frame: Change from pre-intervention (baseline) compared to post-intervention (immediately after session) ]

Study Arms (3)

Isometric exercise-one repetition

EXPERIMENTAL

Isometric exercise consisting of 1 session only. The session will last for around 5 minutes which will include asking the patient to do 1 repetition of wall squat for 3 min or to volitional fatigue at 100° knee angle. Intervention: Other: Single bout of exercise

Other: Single bout of exercise

Isometric exercise-three repetitions

EXPERIMENTAL

isometric exercise consisting of 1 session only. The session will last for around 10 minutes which will include asking the patient to perform 3 repetitions of wall squats (each time the exercise will be performed for 3 min or to volitional fatigue at 100°degree knee angle); the patient will be given 30-sec rest between repetitions. Intervention: Other: Single bout of exercise

Other: Single bout of exercise

Control

NO INTERVENTION

Will not receive any intervention

Interventions

Single bout of exercise OTHER

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.

Isometric exercise-one repetition; Isometric exercise-three repetitions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 18 Years to 65 Years (Adult, Older Adult)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or older; and
• diagnosed with chronic non-specific LBP (lasting for more than 12 weeks).
• Able to perform physical therapy exercises.

You may not qualify if:

• pregnancy.
• patients who have neurological compromise (e.g., cauda equine syndrome or spinal nerve compromise).
• Patients who have spinal pathologies (e.g., fracture, ankylosing spondylitis)
• Uncontrolled diabetic.
• who has any history of heart disease (e.g., myocardial infarction, embolism)
• Orthopaedic impairment (e.g., balance problems)

Sponsors & Collaborators

• Taif University: lead
• King Abdullah Hospital: collaborator

Study Sites (1)

King Abdullah Hospital

Bisha, Saudi Arabia

Location

Study Officials

• Hossam Alzahrani, PhD

  Taif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: March 15, 2023
• Primary Completion: June 5, 2023
• Study Completion: August 5, 2023
• Last Updated: August 5, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)