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Effect of Clinician Expectation Interaction Prior to Motor Control Exercises in Chronic Low Back Pain: A Randomized Controlled Trial

Effect of Clinician Expectation Interaction Prior to Motor ControlExercises in Chronic Low Back Pain: A Randomized ControlledTrial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190427043384N3
Enrollment
120
Registered
2025-06-12
Start date
2025-07-11
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic low back pain. Low back pain M54.5

Interventions

Intervention 1: Intervention group: Group 1: Motor control exercise + clinician’s positive pre-exercise interaction Group. group1 receive 6-week individual motor control exercise program. Prior to

Sponsors

Kharazmi University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Men and women Aged 20–60 years Fluent in Persian (written and spoken) Diagnosis of chronic low back pain for over three months (confirmed by a clinician) Baseline Pain Intensity Score =3 on a Numeric Pain Rating Scale (NPRS). Level of Disability measured with of score greater than 14% on the Oswestry Disability Index (ODI)

Exclusion criteria

Exclusion criteria: Current or past addictive behaviors. History of serious psychiatric disorders. Pregnancy. Participation in structured exercise > 30 min/week or rehabilitation in the past 3 months. Serious spinal pathologies (e.g., tumor, infection, stenosis, herniated disc) and injuries (e.g., fracture) History of spinal surgery. Neurological or cardiovascular diseases Inflammatory or neuropathic back pain Initiation of new medication within 6 weeks prior to the study Severe visual or auditory impairment interfering with protocol adherence

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: 11-point Numerical Pain Rating Scale (NPRS).;Disability. Timepoint: Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: Oswestry Disability Index (ODI).

Secondary

MeasureTime frame
Trunk motion (kinematics). Timepoint: Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: Motion Analysis System.;Muscle activity. Timepoint: Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: Surface EMG (sEMG).;Fear-avoidance beliefs. Timepoint: Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: The Persian version of the Fear-Avoidance Beliefs Questionnaire (FABQ) will be used to assess the patients' fear-avoidance beliefs during physical activity and work. It includes 16 items related to physical activity (FABQ-PA) and work (FABQ-W) affecting the patient’s LBP. As for FABQ-W, those with a score >34 or higher (out of a possible 42 points) have shown to be less likely to return to work by four weeks, whereas, in FABQ-PA, those with a score of 15 (out of a possible 24 points) have revealed Fear-Avoidance beliefs related to physical activities. The Persian version of the FABQ has been reported to be a valid and reliable (ICC= 0.80) measure of Fear-Avoidance beliefs in patients with CLBP. The least clinically significant difference (MCD) in people with CLBP is 5.95.;Self-efficacy. Timepoint: Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: The Persian version of the Pain Self-Efficacy Questionnaire (PSEQ) will be used to assess self-efficacy. The questionnaire has been found to be a valid and reliable (ICC= 0.92) measure of pain self-efficacy beliefs). The PSEQ is a 10-item questionnaire ranging from 0 to 60 to assess patients’ confidence about their ability to perform a range of activities despite pain. For example: “I can do most of the household chores (e.g., tidying up, washing dishes), despite the pain” and “I can gradually increase my activity level, despite the pain. Lower scores for the PSEQ indicate lower levels of confidence. The least clinically significant difference (MCD)

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKharazmi University

Kharazmi University

Ehsanalvani90@gmail.com+98 910 844 7211

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026