- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07766616
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Effects of Adding Acceptance and Commitment Therapy to Physiotherapy Program on Pain Catastrophizing, Stress, Disability, and Sleep Quality in Individuals With Chronic Low Back Pain
This study is a randomized controlled trial (RCT) investigating whether adding Acceptance and Commitment Therapy (ACT) to standard physiotherapy provides greater benefits for adults with chronic low back pain than physiotherapy alone.
A total of 60 participants will be randomly allocated into two groups: ACT plus physiotherapy and physiotherapy alone. Both groups will receive a 8-weeks program with two sessions per week. The ACT component focuses on acceptance, psychological flexibility, mindfulness, cognitive defusion, values, and committed action.
The main outcomes are pain catastrophizing, functional disability, perceived stress, and sleep quality, assessed using the PCS, ODI, PSS, and PSQI. The study aims to determine whether combining psychological and physical rehabilitation produces better outcomes than physiotherapy alone.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Mosab M Aldabbas, PhD
- Puhelinnumero: 00972597451222
- Sähköposti: mosab.m.aldabbas@gmail.com
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
A_Aged between 18-55 years. B_Clinically diagnosed with non-specific chronic low back pain (CLBP). C_Low back pain persisting for more than 3 months.
Exclusion Criteria:
A. History of previous spinal surgeries or invasive interventions in the lumbar region.
B. Presence of "Red Flags" or serious underlying pathologies, such as spinal tumors, infections, or vertebral fractures.
C. Current or recent (within the last 6 months) participation in structured psychological rehabilitation or behavioral therapy programs.
D. Clinical evidence of neurological deficits, radiculopathy, or cauda equina syndrome.
E. Pregnancy, due to the physiological changes affecting musculoskeletal mechanics.
F. Severe behavioral or communication impairments preclude the ability to follow the intervention protocol or complete the self-report assessments.
G. Patients who take any sleep medication or for mental health medication. H. Patients who have done physiotherapy program last 3 months.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: ACT + Physiotherapy
Participants will receive an integrated Acceptance and Commitment Therapy (ACT) and physiotherapy program for 8 weeks, with two sessions per week .
Each session will last approximately 45 minutes, including 15 minutes of ACT and 30 minutes of physiotherapy.
ACT will include acceptance, cognitive defusion, mindfulness, values clarification, and committed action.
Physiotherapy will include lumbar stabilization, core strengthening, aerobic conditioning, soft tissue techniques, and TENS.
|
Participants in the experimental group will receive Acceptance and Commitment Therapy (ACT) as part of the integrated rehabilitation program.
ACT will be delivered for 15 minutes per session, twice weekly for 8 weeks .
The intervention will focus on functional acceptance, psychological flexibility, cognitive defusion, mindfulness and present-moment awareness, values clarification, and committed action.
The program aims to reduce pain catastrophizing and avoidance behaviors and promote engagement in meaningful activities despite chronic low back pain.
ACT will be followed by 30 minutes of physiotherapy during each session.
Participants will receive a standard physiotherapy program twice weekly for 8 weeks .
The program will include lumbar stabilization exercises, core strengthening, flexibility and mobility exercises, aerobic conditioning, soft tissue release, and TENS.
The physiotherapy component aims to improve physical function, mobility, and functional ability in individuals with chronic low back pain.
The same physiotherapy program will be provided to participants in both study arms.
|
|
Active Comparator: Standard Physiotherapy
Participants will receive standard physiotherapy for 8 weeks, with two sessions per week .
The physiotherapy program will include lumbar stabilization exercises, core strengthening, flexibility and mobility exercises, aerobic conditioning, soft tissue techniques, and TENS.
Participants in this group will not receive Acceptance and Commitment Therapy or other ACT-based psychological interventions.
|
Participants will receive a standard physiotherapy program twice weekly for 8 weeks .
The program will include lumbar stabilization exercises, core strengthening, flexibility and mobility exercises, aerobic conditioning, soft tissue release, and TENS.
The physiotherapy component aims to improve physical function, mobility, and functional ability in individuals with chronic low back pain.
The same physiotherapy program will be provided to participants in both study arms.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Sleep Quality
Aikaikkuna: Pre and 8 weeks post intervention
|
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates several aspects of sleep during the previous month.
The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
|
Pre and 8 weeks post intervention
|
|
Pain intensity
Aikaikkuna: Pre and 8 weeks post intervention
|
VAS_Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
|
Pre and 8 weeks post intervention
|
|
Disability
Aikaikkuna: Pre and 8 weeks post intervention
|
Functional disability related to chronic low back pain will be assessed using the Oswestry Disability Index (ODI).
The questionnaire evaluates limitations in daily activities, with the total score expressed as a percentage.
Higher scores indicate greater disability.
|
Pre and 8 weeks post intervention
|
|
Stress
Aikaikkuna: pre and 8 weeks post intervention
|
Perceived stress will be assessed using the Perceived Stress Scale (PSS), which measures the extent to which situations in an individual's life are perceived as unpredictable, uncontrollable, and overwhelming.
Higher scores indicate greater perceived stress.
|
pre and 8 weeks post intervention
|
|
Pain Catastrophizing
Aikaikkuna: Pre and 8 weeks post intervention
|
Pain catastrophizing will be assessed using the 13-item Pain Catastrophizing Scale (PCS), which evaluates rumination, magnification, and helplessness related to pain.
Higher scores indicate greater pain catastrophizing.
|
Pre and 8 weeks post intervention
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- Al azhar AUG
- 000 (Muu tunniste: CTGTY)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .