Cognitive Functional Therapy Compared With Pilates in Elderly Patients With Chronic Low Back Pain

Sponsor

Centro Universitário Augusto Motta (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05480982

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

There is evidence of three randomized controlled trials that face-to-face CFT reduces disability compared with active interventions for adults with chronic low back pain. The pandemic enabled the popularization of tele rehabilitation around the globe, but there are still no clinical trial testing the effectiveness of Cognitive Functional Therapy (CFT) via tele rehabilitation for elderly people with chronic low back pain. The aim of this study is to investigate the effectiveness of CFT compared with Pilates, both via tele rehabilitation in elderly patients with chronic low back pain.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Behavioral: Cognitive functional therapy via tele rehabilitation Other: Pilates via tele rehabilitation	N/A

Detailed Description

This will be a parallel-group randomized controlled trial with intention to treat analysis conducted via tele rehabilitation in Brazil. Two hundreds elderly people with chronic low back pain (except low risk on STartback screening tool) will be randomized to receive CFT (2 individualized sessions and 4-8 group sessions) or group Pilates (6-10 sessions) up to 12 weeks treatment. Participants will be assessed at baseline, post-intervention (12 weeks) 24 and 48 weeks after randomization. The trial will include cost-effectiveness and cost-utility analyses. Data of quality of life, healthcare costs, patient and family costs, and absenteism costs will be collected. The cost-effectiveness analysis will be performed using disability and pain intensity as outcomes. Costs and quality-adjusted life years will be used to calculate cost-utility.

Three qualitative studies will be conducted during the trial. The first will be performed by means of the interviews with a subsample of the participants before randomization. The aim will be to investigate how elderly people with chronic low back pain perceive their condition. The second will be performed by means of the analysis of a subsample of video recordings of CFT treatments. The aim will be to investigate the narratives of elderly people with chronic low back pain during CFT treatment sessions. The third will be performed after the last follow up by means of an interview with a subsample of participants that received CFT treatment. The aim will be to investigate the perceptions of elderly people with chronic low back pain about the impact of CFT via telerehabilitation.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled clinical trial with allocation of two parallel groupsRandomized controlled clinical trial with allocation of two parallel groups

Masking:

Single (Investigator)

Masking Description:

The assessors were not considered blinded because participants were not blinded and outcomes were self-reported. However, to guarantee that the treatment expectation was evenly balanced between the groups and decrease measurement bias, the participants did not know the study hypothesis, and the assessors did not know the participant's intervention group. The statistician was blinded to the group allocation.

Primary Purpose:

Treatment

Official Title:

Cognitive Functional Therapy Compared With Pilates in Elderly Patients With Chronic Low Back Pain Treated Via Telerehabilitation: A Randomized Controlled Trial

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive functional therapy (CFT) via tele rehabilitation Cognitive Functional Therapy (CFT) is a physiotherapy-led intervention which has evolved from an integration of foundational behavioral psychology and neuroscience within the physiotherapy practice directed at the multidimensional biopsychosocial nature of low back pain. The clinical journey is adapted to the individual's profile following three main components: (i) making sense of pain, (ii) exposure with control and (iii) lifestyle changes. The first 2 one-hour treatment sessions of CFT will be delivered individually and via videoconference in a weekly basis. The following one-hour treatment sessions (from 6 to 9 sessions) will be delivered in groups (up to 6 participants). One group booster session will be delivered 20 weeks after randomization	Behavioral: Cognitive functional therapy via tele rehabilitation Participants in the CFT group will be treated by a physiotherapist with seventeen years of clinical experience and that has attended six CFT workshops with three of the international tutors of the method. She has completed 212 hours of training including workshops, patient examinations and a pilot study under the supervision of a physiotherapist with more than seven years of clinical experience in CFT. Another two physiotherapists, one with more than fifteen years and the other with more than ten years of clinical experience, and both with more than 106 hours of CFT training including CFT via tele physiotherapy, will complete the staff.
Active Comparator: Pilates Participants in the comparison group will receive Pilates method using classic principles and exercises recommended by Joseph Pilates. No specific accessories or equipment will be used, allowing the exercises to be performed under any circumstances. Based on Pilates, 10 exercises were selected: Leg Pull Front, One Leg Circle, One Leg Kick, One leg stretch, Shoulder bridge, Side bend, Spine Stretch , Swimming, The hundred and The Saw. The main objective of the exercises is to improve physical capacities, including mobility, flexibility, muscle strength and activation of the "power house" center of force, with the therapeutic aim of a positive evolution of chronic non-specific low back pain. The one-hour sessions will be delivered once a week. Participants will be instructed to perform the set of exercises once a week without the supervision of the physiotherapist. The number of group sessions (up to 6 participants) will vary between 8 to 12.	Other: Pilates via tele rehabilitation Physiotherapist will have the freedom to judge about the exercises´ progression and the need of adaptation considering both the level of difficulty to perform each exercise according to the original proposal and the individual´s demands. The treating physiotherapists will have at least 2 years of clinical practice in Pilates and clinical experience in Pilates via teleconference.

Arm

Intervention/Treatment

Experimental: Cognitive functional therapy (CFT) via tele rehabilitation

Cognitive Functional Therapy (CFT) is a physiotherapy-led intervention which has evolved from an integration of foundational behavioral psychology and neuroscience within the physiotherapy practice directed at the multidimensional biopsychosocial nature of low back pain. The clinical journey is adapted to the individual's profile following three main components: (i) making sense of pain, (ii) exposure with control and (iii) lifestyle changes. The first 2 one-hour treatment sessions of CFT will be delivered individually and via videoconference in a weekly basis. The following one-hour treatment sessions (from 6 to 9 sessions) will be delivered in groups (up to 6 participants). One group booster session will be delivered 20 weeks after randomization

Behavioral: Cognitive functional therapy via tele rehabilitation

Participants in the CFT group will be treated by a physiotherapist with seventeen years of clinical experience and that has attended six CFT workshops with three of the international tutors of the method. She has completed 212 hours of training including workshops, patient examinations and a pilot study under the supervision of a physiotherapist with more than seven years of clinical experience in CFT. Another two physiotherapists, one with more than fifteen years and the other with more than ten years of clinical experience, and both with more than 106 hours of CFT training including CFT via tele physiotherapy, will complete the staff.

Active Comparator: Pilates

Participants in the comparison group will receive Pilates method using classic principles and exercises recommended by Joseph Pilates. No specific accessories or equipment will be used, allowing the exercises to be performed under any circumstances. Based on Pilates, 10 exercises were selected: Leg Pull Front, One Leg Circle, One Leg Kick, One leg stretch, Shoulder bridge, Side bend, Spine Stretch , Swimming, The hundred and The Saw. The main objective of the exercises is to improve physical capacities, including mobility, flexibility, muscle strength and activation of the "power house" center of force, with the therapeutic aim of a positive evolution of chronic non-specific low back pain. The one-hour sessions will be delivered once a week. Participants will be instructed to perform the set of exercises once a week without the supervision of the physiotherapist. The number of group sessions (up to 6 participants) will vary between 8 to 12.

Other: Pilates via tele rehabilitation

Physiotherapist will have the freedom to judge about the exercises´ progression and the need of adaptation considering both the level of difficulty to perform each exercise according to the original proposal and the individual´s demands. The treating physiotherapists will have at least 2 years of clinical practice in Pilates and clinical experience in Pilates via teleconference.

Outcome Measures

Primary Outcome Measures

Disability [12 weeks after randomization]
Quebec Back Pain Disability Scale (0-100), higher scores mean worse outcome

Secondary Outcome Measures

Pain intensity [12 weeks, 24 weeks and 48 weeks after randomization]
Numerical Pain Rating Scale (0-10), higher scores mean a worse outcome
Disability [24 weeks and 48 weeks after randomization]
Quebec Back Pain Disability Scale (0-100), higher scores mean a worse outcome
Function [12 weeks, 24 weeks and 48 weeks after randomization]
Patient Specific Functional Scale (0-10), higher scores mean better outcome
Anxiety [12 weeks, 24 weeks and 48 weeks after randomization]
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
Depression [12 weeks, 24 weeks and 48 weeks after randomization]
Brief Psychosocial Questions (0-10),higher scores mean a worse outcome
Catastrophization [12 weeks, 24 weeks and 48 weeks after randomization]
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
Fear of movement [12 weeks, 24 weeks and 48 weeks after randomization]
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
Social isolation [12 weeks, 24 weeks and 48 weeks after randomization]
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
Stress [12 weeks, 24 weeks and 48 weeks after randomization]
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
Sleep disturbance [12 weeks, 24 weeks and 48 weeks after randomization]
Subjective Health Complaints Inventory (0-3), higher scores mean a worse outcome
Costs [12 weeks, 24 weeks and 48 weeks after randomization]
Assessments of healthcare costs, patients and family costs, and absenteeism costs by a specific questionnaire (total costs in £)
Quality-adjusted life years [12 weeks, 24 weeks and 48 weeks after randomization]
SF-6D questionnaire (0-1), higher scores mean a better outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A main complaint of pain in the area between the 12th rib and buttock crease with or without accompanying non-radicular leg pain;
Episode of ongoing low back pain for at least 12 weeks' duration;
Presenting to a primary care clinician at least 6 weeks ago for this episode of LBP;
Being able to walk independently (with or without aids);
Ability to understand Portuguese well enough to be able to fill in the questionnaires.
Medium or high risk score on STartback screening tool.

Exclusion Criteria:

Known or suspected red flag disorders like fracture, malignancy/cancer, cauda equina syndrome or progressive neurological disorder, inflammatory or infective diseases of the spine;
Suspected radicular pain (dominant leg pain, positive neural tissue provocation tests and/or any two of altered strength, reflexes or sensation for the same nerve root, assessed clinically);
Spinal surgery < 6 months previously;
Invasive procedures for pain relief (ex: epidural injection, rhizotomy) in the last three months;
Scoliosis (if considered the primary cause of pain);
Unstable heart conditions;
Chikungunya or Dengue virus disease transmitted by mosquitoes;
Relevant cognition deficit measured by 10 point cognitive screener, with a cut-off point of less than 8 points, 18 for participants with elementary education, and 26 for participants with secondary and/or higher education;
Post Covid-19 sequelae of pain.