Elbow StiffessTRICEPSNCT07907614
Comparison of GMI, PNF, and Standard Care for Post-Traumatic Elbow Stiffness Rehabilitation in Adults
A study testing Standard Multidisciplinary Rehabilitation, Graded Motor Imagery (GMI) and Proprioceptive Neuromuscular Facilitation (PNF) - Hold-Relax in people with Elbow Stiffess and Rehabilitation Treatment, run by Centre Hospitalier de Valenciennes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Elbow Stiffess, Rehabilitation Treatment
- What is being tested?
- Standard Multidisciplinary Rehabilitation, Graded Motor Imagery (GMI) and Proprioceptive Neuromuscular Facilitation (PNF) - Hold-Relax
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2026to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier de Valenciennes
Valenciennes, Hauts-de-France, 59300
Valérie Millul, PhD, 03.27.14.34.24 ext. +33, millul-v@ch-valenciennes.fr
Benjamin Dervaux, PhD
About this study
Official title: Open-label Randomized Interventional Study Comparing the Efficacy of Graded Motor Imagery (GMI) and Proprioceptive Neuromuscular Facilitation (PNF) Protocols With Standard Care in the Rehabilitation of Post-traumatic Elbow Stiffness in Adults.
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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Elbow Stiffess, Rehabilitation Treatment
- Being tested
- Standard Multidisciplinary Rehabilitation, Graded Motor Imagery (GMI), Proprioceptive Neuromuscular Facilitation (PNF) - Hold-Relax
- Keywords
- Post-traumatic elbow stiffness, Elbow fracture, Rehabilitation, Graded Motor Imagery, Proprioceptive Neuromuscular Facilitation, DASH
- Medical subject headings
- Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Multidisciplinary RehabilitationOther
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.
Graded Motor Imagery (GMI)Behavioural
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.
Proprioceptive Neuromuscular Facilitation (PNF) - Hold-RelaxOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Alone | Active comparator | Participants receive standard multidisciplinary rehabilitation for 6 weeks, including physiotherapy 5 times per week, occupational therapy 5 times per week, and a psychological assessment at the beginning of treatment. Participants also perform a prescribed independent exercise program for 20 to 30 minutes per day, 7 days per week. The rehabilitation program includes 30 minutes of physiotherapy with passive stretching, 30 minutes of occupational therapy focused on upper-limb function, and 30 minutes of independent exercises. Receives: Other: Standard Multidisciplinary Rehabilitation |
| Standard Care Plus Graded Motor Imagery (GMI) | Experimental | Participants receive standard multidisciplinary rehabilitation for 6 weeks, with Graded Motor Imagery (GMI) integrated into the rehabilitation program. The GMI intervention consists of three successive 2-week phases: left-right discrimination, imagined movements, and mirror-based visual feedback. The program includes 30 minutes of physiotherapy with passive stretching, 30 minutes of occupational therapy incorporating GMI, and 30 minutes of independent exercises. The total rehabilitation time is kept equivalent across the three study groups. Receives: Other: Standard Multidisciplinary Rehabilitation; Behavioral: Graded Motor Imagery (GMI) |
| Standard Care Plus Proprioceptive Neuromuscular Facilitation (PNF) | Experimental | Participants receive standard multidisciplinary rehabilitation for 6 weeks, with Proprioceptive Neuromuscular Facilitation (PNF) using the Hold-Relax technique integrated into physiotherapy. PNF sessions are delivered by a physiotherapist 5 times per week and replace passive stretching within the 30-minute physiotherapy session. Participants also receive 30 minutes of occupational therapy focused on upper-limb function and perform 30 minutes of independent exercises. The total rehabilitation time is kept equivalent across the three study groups. Receives: Other: Standard Multidisciplinary Rehabilitation; Other: Proprioceptive Neuromuscular Facilitation (PNF) - Hold-Relax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper-limb functional capacity assessed by the DASH score at 6 weeks
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.
Measured: 6 weeks after treatment initiation
Secondary outcomes (12)
Upper-limb functional capacity assessed by the DASH score at 3 months after treatment
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.
Measured: 3 months after the end of treatment (18 weeks after inclusion)
Isometric elbow flexor and extensor muscle strength at 6 weeks
Isometric strength of the elbow flexor and extensor muscles will be measured and compared between the three study groups.
Measured: 6 weeks after treatment initiation
Isometric elbow flexor ans extensor muscle strength at 3-month follow-up
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.
Measured: 3 months after the end of treatment (18 weeks after inclusion)
Active elbow and forearm range of motion at 6 weeks
Active elbow flexion and extension and forearm pronation and supination will be measured to assess changes in joint range of motion.
Measured: 6 weeks after treatment initiation
Active elbow and forearm range of motion at 3-month follow-up
Active elbow flexion and extension and forearm pronation and supination will be measured to assess the maintenance of treatment effects.
Measured: 3 months after the end of treatment (18 weeks after inclusion)
Pain intensity before and after rehabilitation sessions
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.
Measured: Before and immediately after each rehabilitation session during the 6-week treatment period
Pain intensity at 6 weeks
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.
Measured: 6 weeks after treatment initiation
Pain intensity at 3-month follow-up
Pain intensity will be assessed using a 0-10 numeric rating scale to evaluate the maintenance of treatment effects.
Measured: 3 months after the end of treatment (18 weeks after inclusion)
Kinesiophobia assessed by the short TAMPA scale at 6 weeks
Kinesiophobia will be assessed using the short version of the Tampa Scale to compare the effects of the three rehabilitation protocols after treatment.
Measured: 6 weeks after treatment initiation
Kinesiophobia assessed by the short TAMPA scale at 3-month follow-up
Kinesiophobia will be assessed using the short version of the Tampa Scale to evaluate the maintenance of treatment effects.
Measured: 3 months after the end of treatment (18 weeks after inclusion)
Health-related quality of life assessed by the EQ-5D-5L at 6 weeks
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).
Measured: 6 weeks after treatment initiation
Health-related quality of life assessed by the EQ-5D-5L at 3-month follow-up
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.
Measured: 3 months after the end of treatment (18 weeks after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Elbow StiffessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valenciennes
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Benjamin Dervaux, PhD, Principal investigator, CH de Valenciennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907614
- Sponsor's protocol ID
- 2026-01
- Acronym
- TRICEPS
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piacenza A, Zerilli A, Viccari I, Castelli G. Effectiveness of conservative treatment in the management of post-traumatic elbow stiffness: A systematic review. Musculoskelet Sci Pract. 2024 Nov;74:103194. doi: 10.1016/j.msksp.2024.103194. Epub 2024 Sep 26.
PubMed 39342760Birinci T, Kaya Mutlu E, Altun S. The efficacy of graded motor imagery in post-traumatic stiffness of elbow: a randomized controlled trial. J Shoulder Elbow Surg. 2022 Oct;31(10):2147-2156. doi: 10.1016/j.jse.2022.05.031. Epub 2022 Jul 5.
PubMed 35803550Polli A, Moseley GL, Gioia E, Beames T, Baba A, Agostini M, Tonin P, Turolla A. Graded motor imagery for patients with stroke: a non-randomized controlled trial of a new approach. Eur J Phys Rehabil Med. 2017 Feb;53(1):14-23. doi: 10.23736/S1973-9087.16.04215-5. Epub 2016 Jul 21.
PubMed 27442717Birinci T, Razak Ozdincler A, Altun S, Kural C. A structured exercise programme combined with proprioceptive neuromuscular facilitation stretching or static stretching in posttraumatic stiffness of the elbow: a randomized controlled trial. Clin Rehabil. 2019 Feb;33(2):241-252. doi: 10.1177/0269215518802886. Epub 2018 Oct 10.
PubMed 30304958Hindle KB, Whitcomb TJ, Briggs WO, Hong J. Proprioceptive Neuromuscular Facilitation (PNF): Its Mechanisms and Effects on Range of Motion and Muscular Function. J Hum Kinet. 2012 Mar;31:105-13. doi: 10.2478/v10078-012-0011-y. Epub 2012 Apr 3.
PubMed 23487249Davila SA, Johnston-Jones K. Managing the stiff elbow: operative, nonoperative, and postoperative techniques. J Hand Ther. 2006 Apr-Jun;19(2):268-81. doi: 10.1197/j.jht.2006.02.017.
PubMed 16713873Morrey BF, Askew LJ, Chao EY. A biomechanical study of normal functional elbow motion. J Bone Joint Surg Am. 1981 Jul;63(6):872-7.
PubMed 7240327Siemensma MF, van der Windt AE, van Es EM, Colaris JW, Eygendaal D. Management of the stiff elbow: a literature review. EFORT Open Rev. 2023 May 9;8(5):351-360. doi: 10.1530/EOR-23-0039.
PubMed 37158372Schneider MM, Rentschler V, Geyer S, Jung C, Hollinger B, Pfalzer F, Beitzel K, Burkhart K, Schoch C. Rehabilitation after surgical release of the stiff elbow: A literature review. J Orthop. 2024 Nov 10;64:51-58. doi: 10.1016/j.jor.2024.10.061. eCollection 2025 Jun.
PubMed 39691650
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Randomized Interventional Study Comparing the Efficacy of Graded Motor Imagery (GMI) and Proprioceptive Neuromuscular Facilitation (PNF) Protocols With Standard Care in the Rehabilitation of Post-traumatic Elbow Stiffness in Adults.
- ClinicalTrials.gov ID
- NCT07907614
- Acronym / sponsor ID
- TRICEPS / 2026-01
- Conditions
- Elbow Stiffess, Rehabilitation Treatment
- Keywords
- Post-traumatic elbow stiffness, Elbow fracture, Rehabilitation, Graded Motor Imagery, Proprioceptive Neuromuscular Facilitation, DASH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre Hospitalier de ValenciennesResearch network
- Study start
- Dec 2026 (estimated)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Care Alone | Active comparator | Other: Standard Multidisciplinary RehabilitationParticipants receive standard multidisciplinary rehabilitation for 6 weeks, including physiotherapy 5 times per week, occupational therapy 5 times per week, and a psychological assessment at the beginning of treatment. Participants also perform a prescribed independent exercise program for 20 to 30 minutes per day, 7 days per week. The rehabilitation program includes 30 minutes of physiotherapy with passive stretching, 30 minutes of occupational therapy focused on upper-limb function, and 30 minutes of independent exercises. |
| Standard Care Plus Graded Motor Imagery (GMI) | Experimental | Other: Standard Multidisciplinary Rehabilitation, Behavioral: Graded Motor Imagery (GMI)Participants receive standard multidisciplinary rehabilitation for 6 weeks, with Graded Motor Imagery (GMI) integrated into the rehabilitation program. The GMI intervention consists of three successive 2-week phases: left-right discrimination, imagined movements, and mirror-based visual feedback. The program includes 30 minutes of physiotherapy with passive stretching, 30 minutes of occupational therapy incorporating GMI, and 30 minutes of independent exercises. The total rehabilitation time is kept equivalent across the three study groups. |
| Standard Care Plus Proprioceptive Neuromuscular Facilitation (PNF) | Experimental | Other: Standard Multidisciplinary Rehabilitation, Other: Proprioceptive Neuromuscular Facilitation (PNF) - Hold-RelaxParticipants receive standard multidisciplinary rehabilitation for 6 weeks, with Proprioceptive Neuromuscular Facilitation (PNF) using the Hold-Relax technique integrated into physiotherapy. PNF sessions are delivered by a physiotherapist 5 times per week and replace passive stretching within the 30-minute physiotherapy session. Participants also receive 30 minutes of occupational therapy focused on upper-limb function and perform 30 minutes of independent exercises. The total rehabilitation time is kept equivalent across the three study groups. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- Infection of the surgical wound
- Unhealed fracture
- Complex regional pain syndrome
- Peripheral nerve injury
- Lesion requiring further surgery, such as an osteoma or ankylosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Multidisciplinary RehabilitationStandard 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. | Other | Standard Care Alone, Standard Care Plus Graded Motor Imagery (GMI), Standard Care Plus Proprioceptive Neuromuscular Facilitation (PNF) |
| Graded 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. | Behavioural | Standard Care Plus Graded Motor Imagery (GMI) |
| Proprioceptive Neuromuscular Facilitation (PNF) - Hold-RelaxProprioceptive 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. | Other | Standard Care Plus Proprioceptive Neuromuscular Facilitation (PNF) |
Primary outcome
Upper-limb functional capacity assessed by the DASH score at 6 weeks
Time frame: 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.
12 secondary outcomes
Upper-limb functional capacity assessed by the DASH score at 3 months after treatment
Time frame: 3 months after the end of treatment (18 weeks after inclusion)
Isometric elbow flexor and extensor muscle strength at 6 weeks
Time frame: 6 weeks after treatment initiation
Isometric elbow flexor ans extensor muscle strength at 3-month follow-up
Time frame: 3 months after the end of treatment (18 weeks after inclusion)
Active elbow and forearm range of motion at 6 weeks
Time frame: 6 weeks after treatment initiation
Active elbow and forearm range of motion at 3-month follow-up
Time frame: 3 months after the end of treatment (18 weeks after inclusion)
Pain intensity before and after rehabilitation sessions
Time frame: Before and immediately after each rehabilitation session during the 6-week treatment period
Pain intensity at 6 weeks
Time frame: 6 weeks after treatment initiation
Pain intensity at 3-month follow-up
Time frame: 3 months after the end of treatment (18 weeks after inclusion)
Kinesiophobia assessed by the short TAMPA scale at 6 weeks
Time frame: 6 weeks after treatment initiation
Kinesiophobia assessed by the short TAMPA scale at 3-month follow-up
Time frame: 3 months after the end of treatment (18 weeks after inclusion)
Health-related quality of life assessed by the EQ-5D-5L at 6 weeks
Time frame: 6 weeks after treatment initiation
Health-related quality of life assessed by the EQ-5D-5L at 3-month follow-up
Time frame: 3 months after the end of treatment (18 weeks after inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 39342760Piacenza A, Zerilli A, Viccari I, Castelli G. Effectiveness of conservative treatment in the management of post-traumatic elbow stiffness: A systematic review. Musculoskelet Sci Pract. 2024 Nov;74:103194. doi: 10.1016/j.msksp.2024.103194. Epub 2024 Sep 26.
- Background: PubMed 35803550Birinci T, Kaya Mutlu E, Altun S. The efficacy of graded motor imagery in post-traumatic stiffness of elbow: a randomized controlled trial. J Shoulder Elbow Surg. 2022 Oct;31(10):2147-2156. doi: 10.1016/j.jse.2022.05.031. Epub 2022 Jul 5.
- Background: PubMed 27442717Polli A, Moseley GL, Gioia E, Beames T, Baba A, Agostini M, Tonin P, Turolla A. Graded motor imagery for patients with stroke: a non-randomized controlled trial of a new approach. Eur J Phys Rehabil Med. 2017 Feb;53(1):14-23. doi: 10.23736/S1973-9087.16.04215-5. Epub 2016 Jul 21.
- Background: PubMed 30304958Birinci T, Razak Ozdincler A, Altun S, Kural C. A structured exercise programme combined with proprioceptive neuromuscular facilitation stretching or static stretching in posttraumatic stiffness of the elbow: a randomized controlled trial. Clin Rehabil. 2019 Feb;33(2):241-252. doi: 10.1177/0269215518802886. Epub 2018 Oct 10.
- Background: PubMed 23487249Hindle KB, Whitcomb TJ, Briggs WO, Hong J. Proprioceptive Neuromuscular Facilitation (PNF): Its Mechanisms and Effects on Range of Motion and Muscular Function. J Hum Kinet. 2012 Mar;31:105-13. doi: 10.2478/v10078-012-0011-y. Epub 2012 Apr 3.
- Background: PubMed 16713873Davila SA, Johnston-Jones K. Managing the stiff elbow: operative, nonoperative, and postoperative techniques. J Hand Ther. 2006 Apr-Jun;19(2):268-81. doi: 10.1197/j.jht.2006.02.017.
- Background: PubMed 7240327Morrey BF, Askew LJ, Chao EY. A biomechanical study of normal functional elbow motion. J Bone Joint Surg Am. 1981 Jul;63(6):872-7.
- Background: PubMed 37158372Siemensma MF, van der Windt AE, van Es EM, Colaris JW, Eygendaal D. Management of the stiff elbow: a literature review. EFORT Open Rev. 2023 May 9;8(5):351-360. doi: 10.1530/EOR-23-0039.
- Background: PubMed 39691650Schneider MM, Rentschler V, Geyer S, Jung C, Hollinger B, Pfalzer F, Beitzel K, Burkhart K, Schoch C. Rehabilitation after surgical release of the stiff elbow: A literature review. J Orthop. 2024 Nov 10;64:51-58. doi: 10.1016/j.jor.2024.10.061. eCollection 2025 Jun.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Dervaux, PhD principal investigator
CH de Valenciennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Multidisciplinary Rehabilitation, Graded Motor Imagery (GMI) and Proprioceptive Neuromuscular Facilitation (PNF) - Hold-Relax in people with Elbow Stiffess and Rehabilitation Treatment, run by Centre Hospitalier de Valenciennes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Dervaux, PhD (03.27.14.33.29 ext. +33, dervaux-b@ch-valenciennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper-limb functional capacity assessed by the DASH score at 6 weeks (time frame: 6 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07907614, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.