Implementation of the Specific Treatment Of Problems of the Spine Approach in Bangladesh

ConditionChronic Low-back Pain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorMohammad Ali

About this trial

The goal of this implementation trial is to evaluate the clinical outcomes associated with usual physiotherapy care compared to individualized physiotherapy in accordance with the Specific Treatment of Problems of the Spine (STOPS) approach in patients with chronic low back pain (CLBP). The main questions it aims to answer are:

* Is the STOPS approach more effective than usual care physiotherapy among patients with CLBP? * Is STOPS physiotherapy cost-effective compared to usual physiotherapy care for patients with CLBP. * Does STOPS training improve the quality of care among Bangladeshi physiotherapists?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

low back pain, defined as pain between the inferior costal margin and the inferior gluteal fold with or without referral into the leg(s)

referred leg pain, defined as predominately unilateral posterior leg pain extending below the knee, or anterior thigh pain, with or without back pain

Duration of the current episode of primary complaint lasting for greater than 3 months (chronic stage of the injury)

Aged between 18 and 65 (inclusive)

Disqualifiers

Red flag pathologies such as active cancer under current treatment, risk of spinal fracture, signs of potential infection, and major systemic inflammatory disease.

Signs of cauda equina syndrome based on bladder or bowel disturbance and/or imaging

Current pregnancy, or childbirth within the last 6 months, as this could impair the ability to undertake exercises, and could also cause back and leg symptoms that are not related to the subgroups under investigation

Spinal injections within the last 6 weeks, as we wish to study treatment effects independent of the effects of injections

Trial design

Design model

Sequential

Treatments tested in this trial

Usual physiotherapy care
Other intervention
In Phase 1, physiotherapists will provide treatment for participants with chronic low back pain in accordance with their current standard physiotherapy practice. Physiotherapists will be free to choose the treatment approach they wish to.
Individualized (STOPS) physiotherapy
Other intervention
In Phase 3, participants will receive individualized physiotherapy in accordance with the Specific Treatment of Problems of the Spine (STOPS) approach modified for chronic low back pain. Treatment will be individualized on the basis of biopsychosocial assessment findings including dominant pain type (nociceptive, neuropathic or nociplastic), pathoanatomical subgroups (if any), and other barriers to recovery (eg. inflammation, depression, anxiety, stress, catastrophising, pain self-efficacy, and unhelpful motor control strategies). Available treatment strategies will include individualized education/advice, exercise, manual therapy, activity modification/facilitation, goal setting, motor control optimisation, cognitive-behavioural strategies, inflammation management, pain management strategies, sleep management, work management, and relaxation approaches.

Treatment groups

154 Participants

are divided into 2 treatment groups

Group A: Usual physiotherapy careActive comparator 1 intervention

Group B: Individualized (STOPS) physiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Activity limitation

Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability.

Time frame

Primary endpoint will be 26 weeks post-enrolment.

Back Pain Intensity

0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.

Time frame

Primary endpoint will be 26 weeks post-enrolment.

Leg Pain Intensity

0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.

Time frame

Primary endpoint will be 26 weeks post-enrolment.

Secondary outcomes

Work hours missed

Number of work/housework hours missed during the past 7 days (continuous scale from 0 to 50). Lower score indicated less hours missed (better outcome)

Time frame

5, 10, and 26-weeks post enrolment

Work productivity

0-10 numerical rating scale of how much pain affected work productivity in the last 7 days. Score 0-10, with lower scores indicating less interference with work productivity.

Time frame

5, 10, and 26-weeks post enrolment

Short-Form Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-SF)

The total score ranges between 1 and 100, with higher scores indicating a worse outcome.

Time frame

5, 10, and 26-weeks post enrolment

Health-related quality of life (EQ-5D-5L)

Utility scores will be calculated from the EuroQOL-5D-5L, with scores ranging from -0.148 to 0.949 (higher scores indicate better quality of life)

Time frame

5, 10, and 26-weeks post enrolment

Other outcomes

Physiotherapists' self-confidence in low back pain management

Practitioner Self-Confidence Scale. Scored 4-20 where higher scores indicate worse self-confidence towards clinical management of low back pain (worse outcome).

Time frame

After 26 weeks of phases 1 and 3. After the completion of phase 2 training

Physiotherapists' implementation behaviour

Implementation behaviour questionnaire (DIBQ-t) will be used. The questionnaire includes 26 items, with each item rated on a 5-point Likert scale. A total score from 0-100 is derived, with higher scores indicate stronger implementation behaviours. (better outcome)

Time frame

At the end treating the usual care group, and again at the end of treating the individualised (STOPS) physiotherapy group.

Physiotherapists' experiences

Physiotherapists' experiences with implementing usual care and STOPS physiotherapy will be assessed via qualitative semi-structured interviews.

Time frame

At the end treating the usual care group, and again at the end of treating the individualised (STOPS) physiotherapy group.

Treatment effect modifier: Pain type

Pain type (categorised as nociceptive, neuropathic, or nociplastic dominant pain) is being pre-specified as a potential treatment effect modifier on the primary outcome measures. It is hypothesised that patients with neuropathic pain will derive additional benefit of STOPS physiotherapy over usual care.

Time frame

Effect modifiers are measured at baseline, and their potential impact determined on outcomes at week 5, 10, and 26