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Low Back PainNCT06916533

ENBORTH-TR Intervention for Back/Neck Pain

A study testing ENBORTH-TR Intervention and Client-centred Occupational Therapy Intervention Group in people with Low Back Pain and Neck Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Low Back Pain, Neck Pain
What is being tested?
ENBORTH-TR Intervention and Client-centred Occupational Therapy Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Oct 2024to 5 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • University of Health Science

    Ankara

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
ENBORTH-TR Intervention, Client-centred Occupational Therapy Intervention Group
Keywords
low back pain, neck pain, quality of life, sleep quality, occupational performance, satisfaction, kinesiophobia
Medical subject headings
Low Back Pain, Neck Pain, Sleep Initiation and Maintenance Disorders, Personal Satisfaction, Kinesiophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENBORTH-TR InterventionBehavioural

    This intervention program is structured with a multifaceted and holistic approach, starting with the definition of pain and covering topics such as basic body anatomy, functions and pain mechanisms, ergonomics training, environmental regulations, psychosocial factors such as stress, relaxation techniques, sleep and time management.

  • Client-centred Occupational Therapy Intervention GroupBehavioural

    Client-centered occupational therapy intervention consists of 5 stages: (1) Client-centered goal setting, (2) creation of the therapy plan, (3) implementation of interventions, (4) evaluation of results, and (5) obtaining feedback.

Study groups in NCT06916533
Study groupRoleWhat they receive
Control GroupExperimentalAccording to the evaluation results, client-centred occupational therapy intervention was applied to this group. The client-centred occupational therapy intervention is based on the activities that the participants stated in the COPM in the first evaluation and had problems.
Receives: Behavioral: Client-centred Occupational Therapy Intervention Group
ENBORTH-TR Invertention GroupExperimentalIn this study, ENBORTH-TR training programme is applied in addition to person-centred intervention. ENBORTH-TR programme starts from the definition of pain, explains its mechanism, affected muscle groups, and provides awareness training that will improve the quality of life of individuals in pain management such as environmental regulations, relaxation techniques, stress management.
Receives: Behavioral: ENBORTH-TR Intervention; Behavioral: Client-centred Occupational Therapy Intervention Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Canadian Occupational Performance Measure (COPM)

    COPM, which is most frequently used among occupational therapists, is a standardised measurement tool used to determine the individual's activity performance problems and to measure performance satisfaction. In the COPM, which is a semi-structured interview, individuals evaluate their activity preferences with performance and satisfaction scores given by themselves. Individuals are asked about their activity performance problems and concerns about 3 areas including self-care, productivity and leisure time activities. Up to three problems can be identified in each activity area (self-care, productivity, leisure). Performance and satisfaction scores are again determined by the individual between 1 and 10 points.

    Measured: 30 minutes

  2. Visual Analog Scale (VAS)

    Visual analogue scale was used to assess the pain intensity of the participants. During the assessment, the participants were asked to mark the points where they felt pain during sleep, rest and activity on a 10 cm horizontal line with the left end 0 meaning 'no pain' and the right end 10 meaning 'very severe pain'. Before marking, the individuals were explained in detail what they should do. Then, the distance of the marked points to point 0 was measured and recorded in centimetres

    Measured: 5 minutes

  3. Tampa Scale of Kinesiophobia (TSK)

    The TSK, which is used in the evaluation of kinesiophobia, is a Likert-type scale consisting of 17 questions. Each question is scored between 1 and 4 points (1 = strongly disagree to 4 = strongly agree). The lowest score that can be obtained from the scale is 17 and the highest score is 68. A high score in the total score of the scale indicates a high level of kinesiophobia.

    Measured: 7 minutes

  4. Nottingham Health Profile (NHP)

    The NHP used to assess the people's QoL consists of a total of 38 questions. It has 6 subscales and assesses energy, pain, emotional reactions, sleep, social isolation and physical activity. Scoring is done between 0 and 100, with a high score indicating a low QoL.

    Measured: 10 minutes

Secondary outcomes (1)
  1. The Pittsburgh Sleep Quality Index (PSQI)

    Sleep quality was assessed with the PSQI. The scale consisting of 24 questions in total aims to evaluate the sleep quality of the individual in the last month.PSQI consists of 18 items consisting of 7 components in a 1-month period. These items are scored according to a 4-point Likert scale. PSQI is evaluated over 21 points and a score of 5 and above indicates poor sleep quality.

    Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start10 Oct 2024
  3. Primary completion28 Feb 2025
  4. Study completion5 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06916533
Sponsor's protocol ID
2024/209
Status last verified
Mar 2025
First submitted
31 Mar 2025
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ENBORTH-TR Intervention and Client-centred Occupational Therapy Intervention Group in people with Low Back Pain and Neck Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Canadian Occupational Performance Measure (COPM) (time frame: 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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ENBORTH-TR Intervention for Back/Neck Pain | AzTrials