Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Effect of a Gamified Home-Based Core Neuromuscular Training on Pain, Disability, and Core Endurance in Women With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of gamified home-based core neuromuscular training on pain intensity, functional disability, core muscular endurance, and exercise adherence in women with chronic nonspecific low back pain. Participants will be randomly allocated in a 1:1 ratio to either a gamified intervention group or a non-gamified control group. Both groups will perform the same progressive core exercise program. The intervention group will use a digital application with gamification features, while the control group will perform the exercises without gamification. Outcomes will be assessed at baseline and week 4. The study will determine whether gamification provides additional benefits over conventional home-based exercise in improving clinical outcomes and exercise adherence in women with chronic nonspecific low back pain.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Chronic nonspecific low back pain is associated with persistent pain and functional disability. Although home-based core exercises are commonly used in rehabilitation, maintaining exercise adherence can be challenging. Gamification may enhance motivation and engagement through interactive digital features.
This randomized controlled trial will recruit women aged 18-45 years with chronic nonspecific low back pain lasting at least 12 weeks and a baseline moderate pain intensity or more. Participants will be randomly allocated in a 1:1 ratio to a gamified intervention group or a non-gamified control group. Both groups will complete the same progressive home-based core exercise program for 4 weeks, with three sessions per week lasting 20-30 minutes. Exercises will include plank, side plank, foot-elevated side plank, dead bug, and bird dog. The intervention group will use a digital app, while the control group will perform the exercises without gamification.
Assessments will be conducted at baseline and week 4. Pain intensity will be measured using the Numeric Pain Rating Scale, functional disability using the Oswestry Disability Index, core muscular endurance using trunk flexor, trunk extensor, and side-bridge tests, and adherence as the percentage of completed sessions. The study aims to recruit 60 participants. Data will be analyzed using linear mixed-effects models to compare changes between groups over time. Ethical approval was obtained before recruitment, and written informed consent will be obtained from all participants.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Zizi M. Ali, Phd
- Numero di telefono: +966118240798
- Email: zmibrahim@pnu.edu.sa
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Female participants aged 18-45 years.
- Nonspecific low back pain persisting for at least 12 weeks.
- Baseline pain intensity of ≥3 on the Numeric Pain Rating Scale (NPRS).
- Ability to perform the prescribed core exercises safely.
- Ownership of a compatible smartphone.
- Internet access when required.
Exclusion Criteria:
- Specific spinal pathology or serious medical conditions.
- Previous spinal surgery.
- Neurological symptoms affecting the lower limbs.
- Pregnancy.
- Severe musculoskeletal conditions limiting exercise.
- Current participation in another low back pain rehabilitation program.
- Any contraindication to exercise.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Arm 1: Gamified Intervention Group
A four-week home-based core neuromuscular exercise program using a digital application with gamification features. |
a six-week home-based core neuromuscular exercise program using a digital application with gamification features. The program will include three sessions per week, each lasting approximately 20-30 minutes. |
|
Comparatore attivo: Arm 2: Non-Gamified Control Group
Participants will perform the same four-week home-based core neuromuscular exercise program without gamification, with three sessions per week, each lasting approximately 20-30 minutes. |
six-week home-based core neuromuscular exercise program without gamification, with three sessions per week, each lasting approximately 20-30 minutes. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Pain Intensity: Pain Rating Scale (NPRS)
Lasso di tempo: Baseline to Week 4(4weeks).
|
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Changes in pain intensity will be compared between the gamified and non-gamified home-based core neuromuscular training groups. Time Frame: |
Baseline to Week 4(4weeks).
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Oswestry Disability Index
Lasso di tempo: Baseline to Week 4(4weeks)
|
The ODI is a validated, self-administered questionnaire used to assess functional disability associated with low back pain. It consists of 10 sections covering pain intensity and its impact on daily activities, including personal care, lifting, walking, sitting, standing, sleeping, sexual activity, social life, and traveling. Each section contains six response options scored from 0 (no disability) to 5 (maximum disability). The total score is calculated by summing the completed sections and converting it into a percentage: The total score is converted into a percentage by dividing the sum of the completed section scores by the maximum possible score (5 multiplied by the number of completed sections), then multiplying the result by 100. Higher percentages indicate greater functional disability. Interpretation: Minimal (0-20%), Moderate (21-40%), Severe (41-60%), Very severe (61-80%), and Extreme (81-100%). |
Baseline to Week 4(4weeks)
|
|
Core muscle endurance assessment 1
Lasso di tempo: Baseline to Week 4(4weeks)
|
Trunk-Extensor-Test: hold time |
Baseline to Week 4(4weeks)
|
|
Core muscle endurance assessment 2
Lasso di tempo: Baseline to Week 4(4weeks)
|
Trunk Flexor Test: hold time |
Baseline to Week 4(4weeks)
|
|
Core muscle endurance assessment 3
Lasso di tempo: Baseline to Week 4(4weeks)
|
Side Bridge/Side Plank Test: hold time |
Baseline to Week 4(4weeks)
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 26-0740
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .