Different Exercise Trainings in Patients With Chronic Pain From Exercise Adherence, Clinical and Economic Perspectives

NCT05851495 | Completed

• 1 other identifier: hkuirfankucukoglu001
• Study Type: interventional
• Target: 519
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted with 519 patients in order to examine the clinical and cost-effectiveness of different exercise trainings in patients with chronic pain and the adherence of the patients to the exercises given. The patients were divided into 3 groups as home-based exercise groups, physiotherapist-led groups and home-based follow up groups, and traditional physical therapy was applied for a total of 10 sessions. The patients were offered exercises in the form of a brochure to the home-based exercise groups, applied to the exercise group under the guidance of a physiotherapist, and to the home-based follow up groups in a way that reminded them of the exercises by sending a daily text message (SMS) after they were given exercise training accompanied by a physiotherapist. They were told to continue their exercises after the treatment. All groups were evaluated in terms of economic, clinical, quality of life, exercise adherence, and satisfaction three times: before the treatment, after the treatment, and three months after the treatment. Cost utility analysis (QALY) and cost-effectiveness ratio (ICER) were used as part of the economic evaluation. Oswestry Disability Index (ODI) and Neck Disability Index (NDI) were used for clinical evaluation. Quality of life was assessed with the EuroQol General Quality of Life Scale (EQ-5D-5L). A scale consisting of 5 (five) questions prepared by us was used for adherence with the exercise. In the evaluation of satisfaction, individuals were asked to give a score between 0-100. All three groups were called to the hospital for control three months later, and the 5-question scale prepared by us was directed to the patients and it was determined how the given exercises were done.

Conditions

Chronic Pain

Keywords

low back pain; neck pain; exercise adherence; exercise compliance; cost effectiveness analysis; cost utility analysis; economic evaluation; icremental cost effectiveness ratio

Outcome Measures

Primary Outcomes (5)

• Assessment of Exercise Adherence and Patient Satisfaction

  The scale consisting of a total of 5 (five) questions prepared by us three months after the treatment for exercise adherence was directed to the patients. With these questions, the patients' adherence with the exercises given to the patients was asked, the control of whether the given exercises were done correctly was as follows: "0: forgotten, 1: unable to do, 2: correct position but wrong movement, 3: correct position and movement, no respiratory control, and 4: absolutely doing". was evaluated. It was accepted that the patients who scored 3 and 4 points from the exercises remembered the exercises.

  3 months

• Economic Evaluation

  Within the scope of the economic evaluation, cost-utility and cost-effectiveness analyzes of the treatments were made. The cost-utility analysis was calculated from the perspective of the Social Security Institution (SGK) as the ratio of the total payment to the QALY (quality adjusted life years) value. For the cost-effectiveness analysis, it was calculated with the incremental cost-effectiveness ratio (ICER). In terms of the home-based follow up groups, the cost was calculated separately by adding the fees spent for home-based follow up groups purposes in addition to the SGK package fee. The Turkish version of the EQ-5D-5L scale was used to calculate the QALY value. The QALY value was calculated by evaluating the results with Germany score weights. The reason for using Germany point weights is that there is no point weights for our country and Germany point weights are used in cost effectiveness analysis studies.

  3 months

• Oswestry Disability Index

  The Oswestry Disability Index is a widely used scale that measures the functional status of individuals. This scale was first described in 1980 by Fairbank et al. (122). In this scale, which consists of 10 questions in total, each question is between 0-5 points and the highest result that can be obtained from the scale is 50 points. The total score is multiplied by 2 and expressed as a percentage. The Turkish validity and reliability study of the scale, which shows that disability increases as the score obtained from the scale increases, was conducted by Yakut et al. (123).

  3 months

• Neck Disability Index

  The Neck Disability Index is a widely used scale that measures the disability level of individuals related to neck pain. This scale was defined by Vernon and Mior in 1991 (124). Neck Disability Index; It consists of 10 sections that include pain intensity, personal care, lifting, reading, headaches, concentration, work/work, driving, sleep and leisure activities. Each question consists of 6 answer options that measure the severity of pain or limitation. Scoring is done between 0-5. The highest score is 50 and the minimum score can be 0. According to the total score; 0-4: no limitation, 5-14: mild limitation, 15-24: moderate limitation, 25-34: severe limitation, 34 and above: fully restricted (124). The Turkish validity and reliability study of the scale was performed by Telci et al. (125).

  3 months

• Assesment of Quality of Life

  EQ-5D identifier system; It consists of 5 parts: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each part has 5 options: no problem, mild problem, moderate problem, serious problem and extreme problem. The patient is asked to indicate the state of health by ticking the box next to the most appropriate statement in each of the five sections. This decision results in a 1-digit number for that part. The digits of the five parts can be combined into a five-digit number describing the patient's state of health. The 5-digit number obtained from the scale is calculated using Microsoft Excel over the formulas calculated by the EuroQoL group. The answers received from these patients are placed in the program and personal values between 0 and 1 are calculated. According to this score, a value of 0 indicates death and a value of 1 indicates excellent health.

  3 months

Study Arms (3)

home-based exercise groups

NO INTERVENTION

home exercise brochures were given to the home-based exercise groups according to their diagnosis at the end of the treatment. Then, all patients were called to the hospital for control after three months and the scale prepared by us and consisting of a total of 5 (five) questions was directed to the patients and it was determined how the exercises given were performed. Five different exercises were given to patients with low back and neck pain who participated in our study. The patients were asked to do these exercises 3 times a day for 10 repetitions. Cat-camel exercises, lumbar stretching, sit-ups, bridge building and back extensor strengthening exercises were given to patients with low back pain. For patients with neck pain, neck flexion-extension, neck lateral flexion, neck rotation, shoulder capsule stretching and shoulder flexion exercises were given.

physiotherapists-led groups

EXPERIMENTAL

The group involved in physiotherapists-led groups was shown the exercises in practice and under the supervision of the physiotherapist, the patients applied their exercises throughout their treatment. Then, all patients were called to the hospital for control after three months and the scale prepared by us and consisting of a total of 5 (five) questions was directed to the patients and it was determined how the exercises given were performed. Five different exercises were given to patients with low back and neck pain who participated in our study. The patients were asked to do these exercises 3 times a day for 10 repetitions. Cat-camel exercises, lumbar stretching, sit-ups, bridge building and back extensor strengthening exercises were given to patients with low back pain. For patients with neck pain, neck flexion-extension, neck lateral flexion, neck rotation, shoulder capsule stretching and shoulder flexion exercises were given.

Procedure: physiotherapist-led groups, home-based follow up groups

home-based follow up groups

EXPERIMENTAL

Home-based follow up groups, after the exercise training was given to the patients with a physiotherapist, daily text messages (SMS) were sent to the patients and the patients were reminded to do the exercises. Then, all patients were called to the hospital for control after three months and the scale prepared by us and consisting of a total of 5 (five) questions was directed to the patients and it was determined how the exercises given were performed. Five different exercises were given to patients with low back and neck pain who participated in our study. The patients were asked to do these exercises 3 times a day for 10 repetitions. Cat-camel exercises, lumbar stretching, sit-ups, bridge building and back extensor strengthening exercises were given to patients with low back pain. For patients with neck pain, neck flexion-extension, neck lateral flexion, neck rotation, shoulder capsule stretching and shoulder flexion exercises were given.

Procedure: physiotherapist-led groups, home-based follow up groups

Interventions

physiotherapist-led groups, home-based follow up groups PROCEDURE

The group involved in physiotherapists-led groups was shown the exercises in practice and under the supervision of the physiotherapist, the patients applied their exercises throughout their treatment. Home-based follow up groups, after the exercise training was given to the patients with a physiotherapist, daily text messages (SMS) were sent to the patients and the patients were reminded to do the exercises

home-based follow up groups; physiotherapists-led groups

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Continuing low back or neck pain for 3 months or longer
• Mini mental test score more than 24 points
• Being able to speak Turkish
• Being able to be contacted via phone
• The patients participating in the study do not receive any other physiotherapy,

You may not qualify if:

• Patients diagnosed with serious pathologies that may be the main cause of chronic low back pain (presence of lumbar stenosis, spondylolisthesis, fibromyalgia, etc.)
• Patients with a history of spinal surgery
• Patients for whom physiotherapy is contraindicated

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain; Low Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Design

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

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: May 9, 2023
• Study Start: June 18, 2021
• Primary Completion: May 31, 2022
• Study Completion: September 30, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

TU (1)