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

Study Overview
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Brief Summary
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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).

Detailed Description
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Low back pain (LBP) is a common condition that affects many people at some point in their lives. It is estimated that between 5.0% and 10.0% of cases develop chronic low back pain (CLBP), which causes high treatment costs, cessation of work, and suffering. Suffering from LBP is considered one of the main reasons for seeking medical services. Chronic back pain also negatively affects a person's psychological status, in addition to affecting the productivity of workers among them. Exercise training is a fundamental treatment modality for chronic low back pain, knee osteoarthritis, and fibromyalgia. However, pain intensity, kinesiophobia, and low self-efficacy are barriers to initiating and adhering to an exercise training program. Therefore, an effective strategy to reduce these barriers to facilitate participation in an exercise training program for people with chronic musculoskeletal pain conditions is important. A single acute bout of exercise can produce a consistent reduction in pain sensitivity, termed exercise-induced hypoalgesia, in pain-free populations. Although, the hypoalgesia response is likely dependent on the exercise mode or prescription variables applied. In chronic pain populations, exercise-induced hypoalgesia is not always consistent, the optimal exercise dose is largely unknown and there are few studies in people with CLBP, fibromyalgia, and knee osteoarthritis. Research Questions: Is a single bout of exercise effective in improving pain sensitivity and clinical pain in adults with CLBP? Gaps in Existing Knowledge: It is not clear whether a single bout of exercise results in a clinically meaningful reduction in pain sensitivity or clinical pain intensity in people with CLBP. Research Methods: Research design: The design of this study will be a randomized controlled trial. The recruited participants will be assessed for eligibility by one of the physiotherapists. Participants: Ninety participants will be recruited from King Abdullah Hospital, Bisha, Kingdom of Saudi Arabia. This RCT study will recruit participants who are: aged 18 years or older; and diagnosed with chronic non-specific LBP (lasting for more than 12 weeks). The exclusion criteria are: 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) Interventions Eligible 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), Outcomes Pain pressure threshold (difference = exercise-induced hypoalgesia). It will be measured using a digital pressure algometer, FDX®️ (Wagner instrument, Greenwich, USA). Clinical pain at rest (visual analog scale (VAS; 0-10)): functional pain (VAS associated with previously painful movement), expectations of treatment effect. The outcomes will be measured before (baseline) and immediately after the exercise session. Methods Ethics Prior to conducting the study, the research proposal will be submitted to the ethical committee at Taif University to obtain approval to conduct the study. The ethical approval will also be taken from General Administrative for Research & Studies at the Directorate of Health Affairs in Bisha. Consent will be obtained from the patients before participating in the study. Study design: This study design will be a randomized controlled trial with a pre-post control design. Settings: The trial will be performed at the Department of Physiotherapy at King Abdulah Hospital in Bisha, Saudi Arabia. Sample size: Based on sample size calculation following a pilot study conducted in our lab, we plan to enroll 90 participants in the study with symptomatic Chronic Low Back Pain. Participants will be randomly divided into three groups. Each group contains 30 individuals. The aim is to achieve 90% power to observe a significant difference of 5% (alpha of 0.05) using a two-tailed t-test. Sampling techniques: Participants will be recruited using a consecutive sampling technique. Simple randomization will be used to allocate participants in each group. All participants will be given numbers from 1 to 100. Participants who have 1, 4, 7 and etc will be in group 1. Participants who have numbers 2, 5, 8 and etc will be in group 3 whereas participants who have numbers 3,6, 9, and etc will be in group 3. Data analysis: Data will be analyzed using Statistical Package for Social Sciences (SPSS) version 22. Sociodemographic variables and clinical characteristics will be described by means, standard deviations, and frequencies. Generalized linear models will be used to evaluate the effect of the treatment on the outcomes. The statistical analysis will be conducted by an investigator who will be blinded to the subject's intervention group. Safety and adverse events: Exercise programs are generally safe; however, it is possible that participants may experience some unforeseen problems such as muscle soreness, falls, or other injuries. Participants will be closely monitored to keep track of any unwanted effects or problems. If there are any unwanted effects the program may be stopped, and the reasons will be discussed with the treating physiotherapist and investigator. In case of a serious adverse event, participants will be advised to seek immediate medical assistance. Funding: This study did not receive any specific funding.

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

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Other: Single bout of exercise


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isometric exercise-one repetition<br>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<br>* 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.<br>|
| Experimental: Isometric exercise-three repetitions<br>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<br>* 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.<br>|
| No Intervention: Control<br>Will not receive any intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) ] | 
| 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) ] |