Elbow Stiffess, Rehabilitation Treatment
Conditions
Keywords
Post-traumatic elbow stiffness, Elbow fracture, Rehabilitation, Graded Motor Imagery, Proprioceptive Neuromuscular Facilitation, DASH
Brief summary
TRICEPS is a single-center, randomized, open-label, three-arm study evaluating two rehabilitation approaches for post-traumatic elbow stiffness in adults: Graded Motor Imagery (GMI) and Proprioceptive Neuromuscular Facilitation (PNF), each combined with standard care, compared with standard care alone. A total of 75 adults aged 18 to 64 years with post-traumatic elbow stiffness following a fracture will be randomized in a 1:1:1 ratio to one of three groups: standard rehabilitation alone, standard rehabilitation combined with GMI, or standard rehabilitation combined with PNF. The treatment period will last 6 weeks. The primary objective is to compare the effects of these rehabilitation approaches on upper-limb functional capacity, assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) score at baseline and after 6 weeks of treatment. Secondary outcomes include muscle strength, active joint range of motion, pain, kinesiophobia, and health-related quality of life.
Detailed description
Post-traumatic elbow stiffness is a frequent complication following elbow injury and may lead to substantial limitations in upper-limb function and activities of daily living. Conventional rehabilitation includes joint mobilization, stretching, strengthening, and functional exercises. Graded Motor Imagery (GMI) and Proprioceptive Neuromuscular Facilitation (PNF) are rehabilitation approaches that may help improve movement and functional recovery. TRICEPS aims to compare these two approaches, when added to standard rehabilitation, with standard rehabilitation alone. This is a prospective, single-center, randomized, open-label, controlled study with three parallel groups. A total of 75 adults aged 18 to 64 years with post-traumatic elbow stiffness following a fracture will be randomized equally to one of the following groups: 1. \*\*Standard care group:\*\* standard rehabilitation, including physiotherapy, occupational therapy, a psychological assessment at the beginning of treatment, and a home or supervised independent exercise program. 2. \*\*GMI group:\*\* standard rehabilitation combined with Graded Motor Imagery. The GMI program consists of three successive phases over 6 weeks: laterality recognition, imagined movements, and mirror-based visual feedback. 3. \*\*PNF group:\*\* standard rehabilitation combined with Proprioceptive Neuromuscular Facilitation using the Hold-Relax technique, delivered by a physiotherapist. The treatment period lasts 6 weeks. After this period, participants continue rehabilitation according to usual clinical practice in the department. The primary objective is to compare the effectiveness of GMI and PNF, each combined with standard care, with standard care alone in improving upper-limb functional capacity. The primary outcome is the Disabilities of the Arm, Shoulder and Hand (DASH) score, measured at baseline and after 6 weeks of treatment. Secondary objectives are to compare the three groups with regard to muscle strength, active elbow and forearm range of motion, pain during rehabilitation, kinesiophobia, and health-related quality of life. Assessments are performed at baseline and after 6 weeks of treatment; additional follow-up assessments are performed 3 months after the end of treatment for the outcomes specified in the protocol. The planned sample size is 75 participants, with 25 participants allocated to each group.
Interventions
OTHERStandard Multidisciplinary Rehabilitation
Standard multidisciplinary rehabilitation over 6 weeks, consisting of physiotherapy 5 times per week, occupational therapy 5 times per week, a psychological assessment at the beginning of treatment, and a prescribed independent exercise program. Physiotherapy includes passive stretching, and occupational therapy focuses on upper-limb function. The total rehabilitation time is standardized across the three study groups.
BEHAVIORALGraded Motor Imagery (GMI)
Graded Motor Imagery (GMI) integrated into the rehabilitation program over 6 weeks, consisting of three successive 2-week phases: left-right discrimination, imagined movements, and mirror-based visual feedback. The intervention is incorporated into occupational therapy and replaces an equivalent amount of standard rehabilitation time as needed, without increasing the total rehabilitation time.
OTHERProprioceptive Neuromuscular Facilitation (PNF) - Hold-Relax
Proprioceptive Neuromuscular Facilitation (PNF) using the Hold-Relax technique, delivered by a trained physiotherapist 5 times per week over 6 weeks. The technique is integrated into the 30-minute physiotherapy session and replaces passive stretching. The total rehabilitation time remains equivalent to that of the standard care group.
Sponsors
Centre Hospitalier de Valenciennes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, single-center, randomized, open-label, controlled study with three parallel arms. A total of 75 participants will be randomly allocated in a 1:1:1 ratio to one of three groups: standard rehabilitation alone, standard rehabilitation combined with Graded Motor Imagery (GMI), or standard rehabilitation combined with Proprioceptive Neuromuscular Facilitation (PNF). The treatment period lasts 6 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 64 years * Post-traumatic elbow stiffness following an elbow fracture treated surgically or non-surgically * Enrollment 6 to 8 weeks after the initial management of the elbow trauma * Elbow stiffness defined by at least one of the following limitations : flexion less than 130°, extension deficit greater than 30° (extension range less than - 30° as specified in the protocol), supination less than 50°, or pronation less than 50° * Limitation of elbow flexion and/or extension in the sagittal plane * Written, free, informed, and explicit consent to participate in the study * Beneficiary of the French social security system or eligible as a dependent, excluding beneficiaries covered by State Medical Aid (AME)
Exclusion criteria
* Infection of the surgical wound * Unhealed fracture * Complex regional pain syndrome * Peripheral nerve injury * Lesion requiring further surgery, such as an osteoma or ankylosis * Cognitive impairment preventing the patient from understanding the information provided about the study * Limited joint mobility or absence of the contralateral upper limb * Psychiatric, visual, rheumatological, or neurological condition that could compromise the rehabilitation treatment * Under legal guardianship, curatorship, or judicial protection * Detained or deprived of liberty by judicial or administrative decision * Beneficiary of State Medical Aid (Aide Médicale de l'Etat, AME)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper-limb functional capacity assessed by the DASH score at 6 weeks | 6 weeks after treatment initiation | Upper-limb functional capacity will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The DASH score at 6 weeks will be compared between the three study groups, with adjustment for the baseline DASH score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper-limb functional capacity assessed by the DASH score at 3 months after treatment | 3 months after the end of treatment (18 weeks after inclusion) | Upper-limb functional capacity will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire to evaluate the maintenance of treatment effects and compare the three study groups. |
| Isometric elbow flexor and extensor muscle strength at 6 weeks | 6 weeks after treatment initiation | Isometric strength of the elbow flexor and extensor muscles will be measured and compared between the three study groups. |
| Isometric elbow flexor ans extensor muscle strength at 3-month follow-up | 3 months after the end of treatment (18 weeks after inclusion) | Isometric strength of the elbow flexor and extensor muscles will be measured to assess the maintenance of treatment effects and compared between the three study groups. |
| Active elbow and forearm range of motion at 6 weeks | 6 weeks after treatment initiation | Active elbow flexion and extension and forearm pronation and supination will be measured to assess changes in joint range of motion. |
| Active elbow and forearm range of motion at 3-month follow-up | 3 months after the end of treatment (18 weeks after inclusion) | Active elbow flexion and extension and forearm pronation and supination will be measured to assess the maintenance of treatment effects. |
| Pain intensity before and after rehabilitation sessions | Before and immediately after each rehabilitation session during the 6-week treatment period | Pain intensity will be assessed using a 0-10 numeric rating scale immediately before and after each rehabilitation session. The difference between pre-session and post-session pain scores will be assessed. |
| Pain intensity at 6 weeks | 6 weeks after treatment initiation | Pain intensity will be assessed using a 0-10 numeric rating scale to compare pain at the end of the treatment period between the three study groups. |
| Pain intensity at 3-month follow-up | 3 months after the end of treatment (18 weeks after inclusion) | Pain intensity will be assessed using a 0-10 numeric rating scale to evaluate the maintenance of treatment effects. |
| Kinesiophobia assessed by the short TAMPA scale at 6 weeks | 6 weeks after treatment initiation | Kinesiophobia will be assessed using the short version of the Tampa Scale to compare the effects of the three rehabilitation protocols after treatment. |
| Kinesiophobia assessed by the short TAMPA scale at 3-month follow-up | 3 months after the end of treatment (18 weeks after inclusion) | Kinesiophobia will be assessed using the short version of the Tampa Scale to evaluate the maintenance of treatment effects. |
| Health-related quality of life assessed by the EQ-5D-5L at 6 weeks | 6 weeks after treatment initiation | Health-related quality of life will be assessed using the EQ-5D-5L questionnaire, including the health profile, EQ-5D index score, and EQ visual analogue scale (EQ-VAS). |
| Health-related quality of life assessed by the EQ-5D-5L at 3-month follow-up | 3 months after the end of treatment (18 weeks after inclusion) | Health-related quality of life will be assessed using the EQ-5D-5L questionnaire, including the health profile, EQ-5D index score, and EQ visual analogue scale (EQ-VAS), to evaluate the maintenance of treatment effects. |
Countries
France
Contacts
CONTACTBenjamin Dervaux, PhD
PRINCIPAL_INVESTIGATORBenjamin Dervaux, PhD
CH de Valenciennes
Outcome results
None listed