Patient Adherence to a Physical Activity Advice

NCT02996955 | Completed

• 1 other identifier: NL58005.096.16
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is worldwide a common musculoskeletal condition with a high number of recurrences. Recurrence rate and the number of recurrences could be reduced and time to a next episode could be prolonged by advising an active lifestyle. Advising regular physical activity is the mainstay in physical therapy treatment. This includes an appeal to patients to adhere to an activity advice. Patient adherence to an activity advice is poor. In this study an intervention consisting of treatment of illness perceptions with or without organizing social support to increase adherence to an activity advice will be investigated. The primary objective of this study is to investigate whether social support by a partner or friend and treatment of patients' illness perceptions influences the rate of adherence to an activity advice compared to treatment of patients' illness perceptions alone in patients suffering non-specific low back pain. Secondary objectives are; a) whether 'treatment of illness perceptions' changes patients' maladaptive illness perceptions into realistic ones, b) whether maladaptive illness perceptions, comorbidity and/or overweighed/obesity and/or rate of recurrences of non-specific low back pain and/or attitude and intention to physical activity influences patient's adherence . This study is a multi-centre randomized two-arm controlled clinical trial. Patients ≥18 years presenting with at least a second episode of non-specific low back pain. Patients in the intervention and control group will be asked to perform a physical activity advice. During two physiotherapy treatment sessions treatment of illness perceptions is performed in both groups. In the intervention group organizing social support by a partner or friend is added. Twenty-five percent absolute improvement of walking and/or cycling according the NNGB in the intervention group is clinically relevant. During four appointments several questionnaires have to be filled in and during two physiotherapy treatment sessions half an hour treatment of illness perceptions will be performed. Social support by a partner or friend will be organized during the same physiotherapy treatment sessions in the intervention group. During three separate weeks patients have to wear an activity monitor. Patients will be treated according to the Dutch Low Back Pain guideline; no adverse effects will be expected.

Conditions

Patient Adherence

Keywords

Low Back Pain; Social Support; Illness Perceptions; Activity Advice

Outcome Measures

Primary Outcomes (1)

• adherence to the activity advice

  proportion of patients (non)adhering to the activity advice measured by the Activ8

  12 weeks

Secondary Outcomes (1)

• changes in patient's illness perceptions

  base line, one week, 6 and 12 weeks

Other Outcomes (6)

• influence of illness perception on adherence

  12 weeks

• influence of comorbidity on adherence

  12 weeks

• influence of overweight/obesity on adherence

  12 weeks

Study Arms (2)

SoSup group

EXPERIMENTAL

usual care will be provided and social support and treatment of illness perceptions and activity advice and wearing the activ8

Behavioral: social support; Behavioral: treatment of illness perceptions; Device: Activ8; Other: activity advice

C group

ACTIVE COMPARATOR

usual care will be provided and treatment of illness perceptions and activity advice and wearing the Activ8

Behavioral: treatment of illness perceptions; Device: Activ8; Other: activity advice

Interventions

social support BEHAVIORAL

behaviour change intervention

SoSup group

treatment of illness perceptions BEHAVIORAL

educational interview

C group; SoSup group

Activ8 DEVICE

wearing a move monitor

C group; SoSup group

activity advice OTHER

walking or cycling 5 days a week during at least half an hour

C group; SoSup group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-specific low back pain

You may not qualify if:

• Patients physical active in accordance with the Dutch Standard Healthy Physical Activity (NNGB) (Hildebrandt et al., 2007)
• Patients with specific low back pain
• Onset of the low back pain after age 50 years,
• Continuous pain regardless of posture or movement,
• Nocturnal pain,
• General malaise,
• History of malignancy,
• Unexplained weight loss,
• Elevated erythrocyte sedimentation rate (ESR)
• Previous vertebral fracture,
• Older person with hip fracture,
• Prolonged use of corticosteroids,
• Onset of low back pain before age 20 years,
• Iridocyclitis,
• History of unexplained peripheral arthritis or inflammatory bowel disease,

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6200MD, Netherlands

Location

Related Publications (1)

• van Koppen B, Zandwijk P, van Mameren H, de Bie R. Patient adherence to physical activity advice (PAPA) in patients with low back pain: Study protocol for a multicentre randomized controlled trial. Physiother Res Int. 2022 Oct;27(4):e1969. doi: 10.1002/pri.1969. Epub 2022 Aug 17.

  PMID: 35975659 DERIVED

MeSH Terms

Conditions

Patient Compliance; Low Back Pain

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rob de Bie, Prof. PhD

  Maastricht University

  STUDY CHAIR

• Henk v Mameren, Em Prof PhD

  Maastricht University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 19, 2016
• Study Start: November 1, 2016
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)