Clinical trial NCT05331274: The Effect of Structured Pain Education on Pain and Performance Parameters in Patients With Chronic Low Back Pain
Official title: The Effect of Structured Pain Education on Pain and Performance Parameters in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Effect of Structured Pain Education on Pain and Performance Parameters in Patients with Chronic Low Back Pain

The aim of this study is to compare the effects of only Low Load Motor Control Exercises and Pain Education in addition to these exercises on pain, performance, disability and psychological factors, and to present a generalizable pain education in patients with chronic low back pain. We think that DYMK exercises applied together with a general Pain Education given to the patients will provide more improvement on these factors.

The patients will be divided into 2 groups, as a pain training group and an exercise group, with 20 people in each group, in a randomized controlled manner. Only DYMK exercise training will be applied to the exercise group. In the pain training group, pain training will be applied in addition to the DYMK exercise training.

As an evaluation parameter to the participants; Numerical Rating Scale, Short-Form McGill Pain Questionnaire, Pain Catastrophizing Scale, Tampa Kinesiophobia Scale, Roland-Morris Disability Questionnaire, Pain Self-Efficacy Questionnaire, Passive Lumbar Extension Test, Finger-Place Test and Physical Performance Test Battery will be applied. Patients will be evaluated before the start of the study (T0) and at the end of the study (T1).

Low Load Motor Control Exercises will be applied to people in both groups for 4 weeks, 3 days a week, during 20-30 minute sessions. In addition to the DYMK exercise training, a session of 30 to 50 minutes of Pain Training in groups of 4 to 5 people will be given to the patients included in the Pain Training group at the beginning of the exercise training and the exercise training will begin.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old
* Chronic low back pain 3 days a week and ≥ 3 months
* Absence of spinal fracture or acute disc herniation
* Absence of existing psychiatric problems and mental deficiencies
* Absence of exercise contraindications \[28\] \[29\] \[30\]

Exclusion Criteria:

* Being diagnosed with lumbar radiculopathy
* Pain due to tumors or infections, metastases, osteoporosis, inflammatory arthritis or fractures
* Specific medical conditions (neck or back surgery in the previous 3 years, osteoporotic vertebral fractures or rheumatological diseases)
* Chronic widespread pain syndromes (fibromyalgia or chronic fatigue syndrome)
* Receiving any other treatment for chronic low back pain during the study \[28\] \[29\] \[30\]

Primary outcomes:
measure: Change from baseline of pain intensity on the Numerical Rating Scale at 3 weeks
timeFrame: baseline and 3 weeks
measure: Change from baseline in the multidimensional measure of pain on the Short-Form McGill Pain Questionnaire at 3 weeks
timeFrame: baseline and 3 weeks
measure: Change from baseline in assessing feelings, thoughts, and emotions related to pain and disaster on the Pain Catastrophizing Scale at 3 weeks
timeFrame: baseline and 3 weeks
measure: Change from baseline in measuring fear of movement and (re)injury on the Tampa Kinesiophobia Scale at 3 weeks
timeFrame: baseline and 3 weeks
measure: Change from baseline in questioning pain-related disability from low back pain on the Roland Morris Disability Questionnaire at 3 weeks
timeFrame: baseline and 3 weeks
measure: Change from baseline in the patient's ability to perform a range of activities despite pain in the Pain Self-Efficacy Questionnaire at 3 weeks
timeFrame: baseline and 3 weeks
measure: Measuring pain intensity and disability in the Revised Graded Chronic Pain Scale at baseline
timeFrame: baseline
measure: Change from baseline in assessing internal factors and emotions influencing the experience of health-threatening physical injury and pain in the Pain Beliefs Questionnaire at 3 weeks
timeFrame: baseline and 3 weeks
measure: Identifying subjective neuropathic pain experience on the Pain Perception Questionnaire at baseline
timeFrame: baseline
measure: Change from baseline in assessing overall quality of Sleep at 3 weeks
timeFrame: baseline and 3 weeks
Secondary outcomes:
measure: Change from baseline in detecting structural lumbar segmental instability on Passive Lumbar Extension Test at 3 weeks
timeFrame: baseline and 3 weeks
measure: Change from baseline on trunk mobility on the Finger-Place Test at 3 weeks
timeFrame: baseline and 3 weeks
measure: Change from baseline in maintaining a neutral lumbar spine in the Physical Performance Test Battery at 3 weeks
timeFrame: baseline and 3 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Sefakoy Hospital
Study officials:
References: