Clinical trial NCT06916533: ENBORTH-TR Intervention for Back/Neck Pain
Official title: Effectiveness of ENBORTH-TR Intervention on Pain, Quality of Life, Sleep Quality, Kinesiophobia, Perceived Occupational Performance and Satisfaction in Low Back and/or Neck Pain: A Single Blind Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Neck Pain
Keywords: low back pain
neck pain
quality of life
sleep quality
occupational performance
satisfaction
kinesiophobia
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to investigate the effectiveness of the ENBORTH-TR training programme given in addition to client-centred intervention in individuals with low back and/or neck pain. The current study investigates the effect of ENBORTH-TR on pain, quality of life, sleep quality, kinesiophobia and perceived occupational performance and satisfaction levels. This study was designed according to the CONSORT statement, which provides standardisation in randomised controlled trials. In addition, the study was approved by the scientific research ethics committee of a university. Written informed consent was obtained from all participants before the study.

Detailed description: This study was planned as a single-blind randomized controlled trial and was conducted using the CONSORT checklist. Participants who met the inclusion and exclusion criteria and signed the written consent form were divided into 2 groups by simple randomization. While the client-centered intervention procedure was applied to both groups within the scope of the study, the ENBORTH-TR intervention procedure was also applied to the intervention group. All intervention procedures in the study were planned with the telerehabilitation method for 3 days a week for 4 weeks and each session was planned to consist of 45-minute sessions. A total of 136 people were included in the study, 69 in the control group and 67 in the intervention group.

Interventions Client-centered intervention procedure

Using the literature, a client-centered intervention procedure for individuals with low back and/or neck pain was developed. This intervention procedure consists of 5 steps. These steps are as follows:

First phase: Setting measurable, realistic and achievable goals to address occupational performance issues

Second phase: Developing and evaluating the pros and cons of possible solutions by brainstorming on the oupations identified by the Canadian Occupational Performance Measure.

Third stage: Deciding on a solution, making a plan and implementing it. At this stage, adaptations are made to the oupations with problems, a new oupation is chosen and the oupation is prioritized.

Fourth stage Reviewing the results of the client-centered intervention process

Fifth stage: Receiving feedback on the individual's experiences and making changes where necessary.

Client-centered intervention is known as a core component, a historically integrated value and a fundamental element of occupational therapy interventions. It is based on focusing on the individual's values, needs and goals by prioritizing the individuals' own experiences and preferences. Within the scope of the intervention procedure, telerehabilitation method was applied jointly to both groups. In the first evaluations, occupational performance problems were identified according to the Canadian Occupational Performance Measure data. The participants were given a general information about the problem areas and the intervention process and the session contents were planned. In the sessions, it was aimed to step, prioritize, analyze and break down the occupations for low back and/or neck pain, apply specific interventions to the areas of difficulty and adapt the occupation according to individual needs when necessary. Within the framework of a holistic approach, it was aimed to evaluate environmental and psychosocial factors and to identify and support areas that can be intervened.

ENBORTH-TR intervention:

This training program was given to the intervention group in addition to the client-centered intervention. This intervention, which was carried out with the telerehabilitation method, continued for a total of 4 weeks, 3 days a week and 45-minute sessions. The program consists of 5 stages and the content of the training is discussed in detail below. In order to make the program more understandable, the training was carried out with a booklet supported by videos and visuals. The name of the intervention program consists of the initials of the words "Ergoteraphy, Neck, Back, Orthopaedics". This intervention was created by utilizing the literature. The contents of the 5 stages of the intervention are presented below:

Stage 1: Basic Information: Body anatomy, Functions and Pain Mechanisms:

This phase covers sessions 1-3. The main purpose of the sessions is to enable the clients to recognize their bodies and the pain they experience, to gain awareness, to establish a relationship of trust between the therapist and the client and to set goals.

Stage 2: Ergonomics Training and Environmental Arrangements:

In sessions 4-6, clients' living spaces were evaluated and ergonomic adjustments were made for low back and/or neck pain. In addition to these adjustments, joint and energy conservation techniques were taught and information was given about correct movement patterns and body mechanics.

Stage 3: Psychosocial Factors, Sleep and Time Management:

Sessions 7 and 8 focused on psychosocial factors and sleep. Progressive muscle relaxation technique was taught and practiced and sleep diary application was explained. In addition, pre-sleep nutrition and sleep habits were emphasized. Sessions 9 and 10 focused on time management. Time management aims not only to increase productivity, but also to reduce pain, conserve energy and manage stress, thus supporting the individual's participation and quality of life.

Stage 4: Client Feedback At this stage, the extent to which the clients were able to transfer the information learned in the training to daily life was evaluated. At the same time, the training process was also reviewed in general, and areas that were missing or needed to be reinforced were identified. Thus, it was aimed to complete the training in a healthy way

Stage 5: Revisiting Feedback In the last stage, according to the feedback received from the clients, the areas that were not understood or thought to be missing were reconsidered. The training process was completed by answering the questions posed by the clients regarding the training process and the readings.

Statistically analysis Data were analyzed with SPSS version 27.0 statistical software package program. The normality of the data was analyzed by using Kolmogorov-Smirnov test. Nonparametric tests were used because the data did not show a normal distribution. Differences between groups were analyzed with chi-square test for nominal data. Comparisons between the groups were conducted by using the Mann-Whitney U test. Pre- to post-intervention changes within the groups were analyzed with the Wilcoxon signed-rank test. Significance was evaluated at levels of 0.05. Effect size was calculated by using the means and standard deviations of the groups. Effect size benchmarks were determined as \<0.30, 0.30-0.80, and \>0.80 and considered small, moderate, and strong, respectively.

Eligibility criteria: Inclusion Criteria:

* To be at least primary school graduate
* Participating in the study voluntarily
* To be able to read and write Turkish
* At least 24 points from the Mini Mental State Examination
* Having low back and neck pain for 3 months or more
* Being between the ages of 18-65

Exclusion Criteria:

1. Having a neurological, psychiatric or chronic disease (cancer, etc.) or having any secondary disease that will adversely affect the work
2. History of any malignancy or spinal fracture
3. Having undergone a surgical procedure for low back and/or neck pain or having undergone any other surgical intervention within the last 6 months
4. Not participating regularly in the intervention process
5. Participating in another rehabilitation program during the study period

7) Diagnosis of pregnancy or suspected pregnancy

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 30 minutes
measure: Visual Analog Scale (VAS)
timeFrame: 5 minutes
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: 7 minutes
measure: Nottingham Health Profile (NHP)
timeFrame: 10 minutes
Secondary outcomes:
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Science
Study officials:
References: