Distal Radius FractureNCT05883410
The Effect of Two Different Protocol in Wrist Joint Limitation After Distal Radius End Fractures
A study testing Exercise, PNF Technique and Mulligan Mobilization in people with Distal Radius Fracture and Wrist Fracture, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Distal radius fractures are among the most common fractures treated by hand therapists. These patients are most conservatively treated with closed reduction and cast immobilization. Since there is an immobilization process after both treatments, a limitation in the range of motion of the joint occurs in patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fracture, Wrist Fracture
- What is being tested?
- Exercise, PNF Technique and Mulligan Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2023to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be directed to the physiotherapy program after distal radius fracture between the ages of 18-65,
- Having signed the Informed Consent Form
- Patients with good cooperation level
Who cannot join
- Being illiterate of reading and writing
- Having another orthopedic, neurological and cardiovascular problem
- Pre-existing complex regional pain syndrome
- Having had an operation involving the ipsilateral upper extremity in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Proprioceptive Neuromuscular Facilitation-Based Stretching and Mulligan Mobilization on Kinesiophobia and Proprioception in Wrist Joint Limitation After Distal Radius End Fractures
Distal radius fractures are among the most common fractures treated by hand therapists. These patients are most conservatively treated with closed reduction and cast immobilization. Since there is an immobilization process after both treatments, a limitation in the range of motion of the joint occurs in patients. For this reason, most of the treatment models applied in rehabilitation are about restoring the range of motion of the joint. In general, kinesiophobia occurs due to joint limitation and pain. Loss of proprioception occurs in patients with mobility and desire as a result of kinesiophobia. By investigating the techniques used in rehabilitation, the more correct one for the patient can be selected. There is no clear result in the literature about which of the application methods is more effective. The aim of the study is to compare the effects of proprioceptive neuromuscular facilitation (PNF) based stretching and Mulligan mobilization on pain, proprioception (joint position sense), wrist functionality, muscle strength and kinesiophobia in patients with joint limitation after distal radius end fracture. Thirty-four individuals aged 18-65 who were referred to a physiotherapy and rehabilitation program after distal radius end fracture will be included in the study. Individuals will be randomized into two groups. In the study, algometer and Visual Analogue Scale (VAS) were used to evaluate the pain intensity of the patients, universal goniometer for the evaluation of the forearm and wrist joint range of motion, microFET®2 Digital Handheld Dynamometer for the evaluation of the strength of the wrist flexor and extensor muscles, ulnar and radial deviation muscles. device will be used. The functional use of the wrist of the individuals is using the patient-based wrist assessment questionnaire (Patient Graded Wrist Assessment PRWE), the sense of attachment position for proprioception, and the Tampa Kinesiophobia Scale (TKS) for kinesiophobia. In our study, an exercise program will be applied with a physiotherapist for 6 weeks, 2 days a week, 45 minutes. To the first group; In addition to the traditional treatment, Mulligan mobilization will be applied, and the second group will be applied to the PNF techniques, 'hold-relax' in addition to the traditional treatment. It can be considerable that both techniques applied in our study may have positive effects on pain, kinesiophobia and proprioception.
Read the detailed description
The wrist has a complex anatomy and consists of the following structures; bone, ligament, musculotendinous and neurovascular. The distal ends of the radius and ulna are radio-ulnar, radio-carpal and ulno-carpal; carpal bones form midcarpal joints among themselves (1).
The ulna and radius bones articulate with the wrist bones on the distal side, thus providing bony integrity (2).
The wrist joint is the joint region that is most exposed to trauma. Radius distal end fractures account for approximately 20% of fractures admitted to the emergency department and 75% of all forearm fractures. (3).
Distal radius fractures are very common, alone or in combination with other fractures and injuries. For example, in the United States there is an incidence of approximately 67 upper extremity fractures per 10,000 persons per year. Distal radius and ulna fractures account for approximately 25% of all fractures (4).
Distal radius fractures can occur at any age, with a largely bimodal distribution based on age and gender; They are children under 18 and adults over 50 (5).
The overall incidence of DR tip fractures occurring each year is increasing worldwide. For example, a 1998 study by Melton et al. of Rochester, Minnesota, USA documented a 17% increase in DR fractures between 1945 and 1994 (6). Direct trauma is less common in distal radius fractures.
It occurs as a result of direct hitting and impact blows to the distal radius (7). Indirect trauma is more common. Individuals consciously or unconsciously position their elbows in extension, their forearms in pronation, and their wrists in dorsiflexion, and this position, which is defined as falling on an open hand, causes fractures (8). It is very important to determine both the type of fracture and the level of injury well. Thus, the treatment will be easier and the healing process will be accelerated (9).
Fracture healing has been studied in different phases by the researchers. As it is generally known, it consists of three phases; Inflammatory phase, Repair phase, Remodeling phase (10-13).
All these processes require prostaglandins and bone stimulants, which are binding factors. (14,15). According to Wolf's law, skeletal mass and strength are variable according to load distribution (16). It has been observed that compressive axial loads stimulate periosteal callus formation. Shearing and tensile forces have been shown to inhibit union (17).
Displacement, deformation and loads at the fracture site affect the behavior of bone cells, tissue structure, and thus healing. (18).
The primary goals of treatment are to control edema and pain, and to restore normal range of motion to the patient (19). Restoring joint play in patients with resistant joint stiffness will be important in gaining joint range of motion (ROM). Joint mobilization techniques can be used for this purpose (20,21). Movement mobilization (MWM) technique unique to Mulligan Concept, which is one of the mobilization techniques, can be applied safely and effectively in both musculoskeletal and nervous system diseases. Mulligan Concept is functional restoration, techniques are applied in functional positions to improve the daily functions of patients (22).
Stretching, which is a frequently applied method for gaining ROM, can be added to the exercise program as long as fracture healing allows, and by obtaining the opinion of the surgeon with the radiographic findings. In the literature, it has been reported that passive stretching lasting 30 seconds has positive effects on ROM gain when performed repeatedly during the day (23). One of the stretching techniques, Proprioceptive Neuromuscular Facilitation (PNF) based stretching, which is based on the neurophysiological mechanisms of reciprocal innervation and post-isometric relaxation, is one of the active stretching applications that improves mobility, movement control and joint coordination. (24,25).
The consequences of traumatic wrist lesions contribute to proprioceptive and motor control deficits observed in both the acute and post-acute period (26). The aim of rehabilitation after distal radius end fracture is to restore joint mobility and functionality, reduce pain and edema, increase muscle activity through active movement, and train proprioception (27)
Adding mobilization and PNF hold-loose technique to the traditional treatment program may be beneficial in terms of pain, proprioception, muscle strength and kinesiophobia after distal radius end fracture, but it is not known which method will improve more in this patient group. (28).
The aim of the study is to compare the effects of proprioceptive neuromuscular facilitation (PNF) based stretching and Mulligan mobilization on pain, proprioception (joint position sense), wrist functionality, muscle strength and kinesiophobia in patients with joint limitation after distal radius end fracture.
- Conditions
- Distal Radius Fracture, Wrist Fracture
- Being tested
- Exercise, PNF Technique, Mulligan Mobilization
- Keywords
- Distal Radius Fractures, Joint Limitation, Mulligan Mobilization, PNF Technique, Proprioception
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Traditional Exercise Program
It is important for the therapist to organize a home exercise program to provide edema and pain control. The exercise program should be specific and clear to the patient. The exercise program will be taught to the patient and given as a home program
PNF TechniqueOther
While the limb is in the agonist pattern, the patient is instructed to perform isometric contractions for 5-8 seconds against maximum resistance without movement at the limiting point. After maximum isometric contraction, the patient is instructed to actively relax.Participants in the second group will be applied 10 repetitions of isometric contractions for 8 seconds at the limitation points of the movement with the PNF techniques, the hold and relax active movement technique in the direction of wrist flexion and extension.
Mulligan MobilizationOther
In thw Mobilization with movement technique; the patient is expected to perform painless ROM. After obtaining painless movement in the patients participating in the study, this application will be applied to the patient with the painless active movement technique in 10 repetitions and 2-3 sets. Rest time between sets will be 15-20 seconds. Patients will be taught self-mobilization to ensure the continuity of painless movement. Self-mobilization will be applied by the patient at home with 10 repetitions every two hours (29).
| Study group | Role | What they receive |
|---|---|---|
| PNF Treatment Group | Experimental | Hold-relax is a PNF technique will be applied to this group. Receives: Other: Exercise; Other: PNF Technique |
| Mulligan Mobilization Treatment | Active comparator | The Mobilization with movement (MWM) technique will be applied to this group. Receives: Other: Exercise; Other: Mulligan Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Threshold Assessment
The pressure pain threshold in the wrist joint will be recorded by measuring with the Baseline Dolorimeter 66 pounds. In addition to subjective assessment methods, it is necessary to record before and after treatment using this device in order to evaluate pain more objectively and to be expressed in the literature as data with high scientific evidence level.
Measured: 10 minutes
Visual Analog Scale
Visual Analog Scale (VAS) can be used to assess pain which perceived by patients. . VAS is a frequently used scale that indicates the severity of pain numerically. A 10 cm line is divided into 10 equal parts and both ends are numbered from 0 to 10 as the least and maximum pain intensity. Patients are asked to mark the place that best suits their pain intensity.
Measured: 10 minutes
Muscle Strength Assessment
It is planned to use microFET®2 Digital Handheld Dynamometer device to evaluate the strength of wrist flexor and extensor muscles, ulnar and radial deviation muscles. The device has the feature of acquiring objective data and transferring it to a computer. Measurements are recorded in the range of 0-300 lbs. Measurements will be tested with 10 seconds of resistance in the muscle test position. The data of this device are needed to express the weakness in the wrist muscles after the distal radius end fracture as a quantitative value. Thus, the effectiveness of treatment programs can be compared by showing the effect of decreasing muscle strength.
Measured: 8 minutes
Range of Motion Assessment (ROM)
The forearm and wrist joint range of motions will be performed with a universal goniometer in the patient sitting position and on the forearm examination table as degree. Evaluation will take place at weeks 6 and 12 (30-33).
Measured: 10 minutes
Proprioception Assessment
The sensation of kinesthesia is measured by perceiving the minimum degree of motion of the joint per unit time and is generally used as the "passive motion detection threshold" in studies. Joint position sense; It is measured by the ability of a joint at a certain angle to actively or passively repeat the same position. As the error made while repeating the determined target angle decreases, the quality of the sense of joint position increases. Goniometer will be used for evaluation. The patients' deviations from the target angles for the wrist will be recorded as degree (33-37).
Measured: 8 minutes
Tampa Kinesiophobia Scale
It will be used to assess kinesiophobia. The Tampa Kinesiophobia Scale is a self-report measure developed to assess the fear of movement-related pain in patients with musculoskeletal pain. Its items are grouped as activity avoidance and somatic focus, according to two different factors (38,39).The scale is scored with range from 1-4, the negatively worded items are 4,8,12,1 and having a reverse scoring (4-1). The 17 item total scores are ranged from 17 to 68 where the lowest 17 means no kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia
Measured: 10 minutes
Secondary outcomes (1)
Patient Rated Wrist Evaluation (PRWE)
It will be used to evaluate the functionality of patients. The Patient Based Wrist Evaluation (PRWE) is a questionnaire used to determine the level of pain and disability in hand/wrist problems. It includes pain and function subsections and specific activities and daily activities sections. It consists of 15 questions and is a subjective evaluation result scale. The validity and reliability of the scale were determined by evaluating distal radius fractures and wrist injuries. Each response is scored from 0 to 10 (0 = no pain/no difficulty; 10 = maximum pain felt/no ability to do anything). The total score is calculated out of 100, and a high score indicates a higher level of disability (40,41).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start30 May 2023
- Primary completion15 Jul 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Randomized Controlled Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep HOŞBAY, Biruni University
- Investigators
- İrem Guney, PT, Study chair, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883410
- Sponsor's protocol ID
- Biruni Uni
- Status last verified
- Feb 2024
- First submitted
- 13 Apr 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bruder AM, Taylor NF, Dodd KJ, Shields N. Physiotherapy intervention practice patterns used in rehabilitation after distal radial fracture. Physiotherapy. 2013 Sep;99(3):233-40. doi: 10.1016/j.physio.2012.09.003. Epub 2012 Nov 30.
PubMed 23200599Brown PW. Body and soul. J Hand Ther. 1996 Jul-Sep;9(3):201-2. doi: 10.1016/s0894-1130(96)80082-2. No abstract available.
PubMed 8856564Chen NC, Jupiter JB. Management of distal radial fractures. J Bone Joint Surg Am. 2007 Sep;89(9):2051-62. doi: 10.2106/JBJS.G.00020. No abstract available.
PubMed 17768207Karagiannopoulos C, Sitler M, Michlovitz S, Tierney R. A descriptive study on wrist and hand sensori-motor impairment and function following distal radius fracture intervention. J Hand Ther. 2013 Jul-Sep;26(3):204-14; quiz 215. doi: 10.1016/j.jht.2013.03.004. Epub 2013 Apr 28.
PubMed 23628557Cruess RL, Dumont J. Fracture healing. Can J Surg. 1975 Sep;18(5):403-13.
PubMed 1175109Frost HM. Mechanical determinants of bone modeling. Metab Bone Dis Relat Res. 1982;4(4):217-29. doi: 10.1016/0221-8747(82)90031-5.
PubMed 6763662Ilyas AM, Jupiter JB. Distal radius fractures--classification of treatment and indications for surgery. Orthop Clin North Am. 2007 Apr;38(2):167-73, v. doi: 10.1016/j.ocl.2007.01.002.
PubMed 17560399Jerrhag D, Englund M, Karlsson MK, Rosengren BE. Epidemiology and time trends of distal forearm fractures in adults - a study of 11.2 million person-years in Sweden. BMC Musculoskelet Disord. 2017 Jun 2;18(1):240. doi: 10.1186/s12891-017-1596-z.
PubMed 28576135Khan SN, Bostrom MP, Lane JM. Bone growth factors. Orthop Clin North Am. 2000 Jul;31(3):375-88. doi: 10.1016/s0030-5898(05)70157-7.
PubMed 10882464Youdas JW, Krause DA, Egan KS, Therneau TM, Laskowski ER. The effect of static stretching of the calf muscle-tendon unit on active ankle dorsiflexion range of motion. J Orthop Sports Phys Ther. 2003 Jul;33(7):408-17. doi: 10.2519/jospt.2003.33.7.408.
PubMed 12918866Schier JS, Chan J. Changes in life roles after hand injury. J Hand Ther. 2007 Jan-Mar;20(1):57-68; quiz 69. doi: 10.1197/j.jht.2006.10.005.
PubMed 17254909Safi A, Hart R, Teknedzjan B, Kozak T. Treatment of extra-articular and simple articular distal radial fractures with intramedullary nail versus volar locking plate. J Hand Surg Eur Vol. 2013 Sep;38(7):774-9. doi: 10.1177/1753193413478715. Epub 2013 Feb 26.
PubMed 23442339Reyhan AC, Sindel D, Dereli EE. The effects of Mulligan's mobilization with movement technique in patients with lateral epicondylitis. J Back Musculoskelet Rehabil. 2020;33(1):99-107. doi: 10.3233/BMR-181135.
PubMed 31104005Reid SA, Andersen JM, Vicenzino B. Adding mobilisation with movement to exercise and advice hastens the improvement in range, pain and function after non-operative cast immobilisation for distal radius fracture: a multicentre, randomised trial. J Physiother. 2020 Apr;66(2):105-112. doi: 10.1016/j.jphys.2020.03.010. Epub 2020 Apr 11.
PubMed 32291223de Palma L, Tulli A, Maccauro G, Sabetta SP, del Torto M. Fracture callus in osteopetrosis. Clin Orthop Relat Res. 1994 Nov;(308):85-9.
PubMed 7955707
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Proprioceptive Neuromuscular Facilitation-Based Stretching and Mulligan Mobilization on Kinesiophobia and Proprioception in Wrist Joint Limitation After Distal Radius End Fractures
- ClinicalTrials.gov ID
- NCT05883410
- Acronym / sponsor ID
- Biruni Uni
- Conditions
- Distal Radius Fracture, Wrist Fracture
- Keywords
- Distal Radius Fractures, Joint Limitation, Mulligan Mobilization, PNF Technique, Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 1 Jun 2023 (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.
Distal radius fractures are among the most common fractures treated by hand therapists. These patients are most conservatively treated with closed reduction and cast immobilization. Since there is an immobilization process after both treatments, a limitation in the range of motion of the joint occurs in patients. For this reason, most of the treatment models applied in rehabilitation are about restoring the range of motion of the joint. In general, kinesiophobia occurs due to joint limitation and pain. Loss of proprioception occurs in patients with mobility and desire as a result of kinesiophobia. By investigating the techniques used in rehabilitation, the more correct one for the patient can be selected. There is no clear result in the literature about which of the application methods is more effective. The aim of the study is to compare the effects of proprioceptive neuromuscular facilitation (PNF) based stretching and Mulligan mobilization on pain, proprioception (joint position sense), wrist functionality, muscle strength and kinesiophobia in patients with joint limitation after distal radius end fracture. Thirty-four individuals aged 18-65 who were referred to a physiotherapy and rehabilitation program after distal radius end fracture will be included in the study. Individuals will be randomized into two groups. In the study, algometer and Visual Analogue Scale (VAS) were used to evaluate the pain intensity of the patients, universal goniometer for the evaluation of the forearm and wrist joint range of motion, microFET®2 Digital Handheld Dynamometer for the evaluation of the strength of the wrist flexor and extensor muscles, ulnar and radial deviation muscles. device will be used. The functional use of the wrist of the individuals is using the patient-based wrist assessment questionnaire (Patient Graded Wrist Assessment PRWE), the sense of attachment position for proprioception, and the Tampa Kinesiophobia Scale (TKS) for kinesiophobia. In our study, an exercise program will be applied with a physiotherapist for 6 weeks, 2 days a week, 45 minutes. To the first group; In addition to the traditional treatment, Mulligan mobilization will be applied, and the second group will be applied to the PNF techniques, 'hold-relax' in addition to the traditional treatment. It can be considerable that both techniques applied in our study may have positive effects on pain, kinesiophobia and proprioception.
Detailed description
The wrist has a complex anatomy and consists of the following structures; bone, ligament, musculotendinous and neurovascular. The distal ends of the radius and ulna are radio-ulnar, radio-carpal and ulno-carpal; carpal bones form midcarpal joints among themselves (1).
The ulna and radius bones articulate with the wrist bones on the distal side, thus providing bony integrity (2).
The wrist joint is the joint region that is most exposed to trauma. Radius distal end fractures account for approximately 20% of fractures admitted to the emergency department and 75% of all forearm fractures. (3).
Distal radius fractures are very common, alone or in combination with other fractures and injuries. For example, in the United States there is an incidence of approximately 67 upper extremity fractures per 10,000 persons per year. Distal radius and ulna fractures account for approximately 25% of all fractures (4).
Distal radius fractures can occur at any age, with a largely bimodal distribution based on age and gender; They are children under 18 and adults over 50 (5).
The overall incidence of DR tip fractures occurring each year is increasing worldwide. For example, a 1998 study by Melton et al. of Rochester, Minnesota, USA documented a 17% increase in DR fractures between 1945 and 1994 (6). Direct trauma is less common in distal radius fractures.
It occurs as a result of direct hitting and impact blows to the distal radius (7). Indirect trauma is more common. Individuals consciously or unconsciously position their elbows in extension, their forearms in pronation, and their wrists in dorsiflexion, and this position, which is defined as falling on an open hand, causes fractures (8). It is very important to determine both the type of fracture and the level of injury well. Thus, the treatment will be easier and the healing process will be accelerated (9).
Fracture healing has been studied in different phases by the researchers. As it is generally known, it consists of three phases; Inflammatory phase, Repair phase, Remodeling phase (10-13).
All these processes require prostaglandins and bone stimulants, which are binding factors. (14,15). According to Wolf's law, skeletal mass and strength are variable according to load distribution (16). It has been observed that compressive axial loads stimulate periosteal callus formation. Shearing and tensile forces have been shown to inhibit union (17).
Displacement, deformation and loads at the fracture site affect the behavior of bone cells, tissue structure, and thus healing. (18).
The primary goals of treatment are to control edema and pain, and to restore normal range of motion to the patient (19). Restoring joint play in patients with resistant joint stiffness will be important in gaining joint range of motion (ROM). Joint mobilization techniques can be used for this purpose (20,21). Movement mobilization (MWM) technique unique to Mulligan Concept, which is one of the mobilization techniques, can be applied safely and effectively in both musculoskeletal and nervous system diseases. Mulligan Concept is functional restoration, techniques are applied in functional positions to improve the daily functions of patients (22).
Stretching, which is a frequently applied method for gaining ROM, can be added to the exercise program as long as fracture healing allows, and by obtaining the opinion of the surgeon with the radiographic findings. In the literature, it has been reported that passive stretching lasting 30 seconds has positive effects on ROM gain when performed repeatedly during the day (23). One of the stretching techniques, Proprioceptive Neuromuscular Facilitation (PNF) based stretching, which is based on the neurophysiological mechanisms of reciprocal innervation and post-isometric relaxation, is one of the active stretching applications that improves mobility, movement control and joint coordination. (24,25).
The consequences of traumatic wrist lesions contribute to proprioceptive and motor control deficits observed in both the acute and post-acute period (26). The aim of rehabilitation after distal radius end fracture is to restore joint mobility and functionality, reduce pain and edema, increase muscle activity through active movement, and train proprioception (27)
Adding mobilization and PNF hold-loose technique to the traditional treatment program may be beneficial in terms of pain, proprioception, muscle strength and kinesiophobia after distal radius end fracture, but it is not known which method will improve more in this patient group. (28).
The aim of the study is to compare the effects of proprioceptive neuromuscular facilitation (PNF) based stretching and Mulligan mobilization on pain, proprioception (joint position sense), wrist functionality, muscle strength and kinesiophobia in patients with joint limitation after distal radius end fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| PNF Treatment Group | Experimental | Other: Exercise, Other: PNF TechniqueHold-relax is a PNF technique will be applied to this group. |
| Mulligan Mobilization Treatment | Active comparator | Other: Exercise, Other: Mulligan MobilizationThe Mobilization with movement (MWM) technique will be applied to this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be directed to the physiotherapy program after distal radius fracture between the ages of 18-65,
- Having signed the Informed Consent Form
- Patients with good cooperation level
Key exclusion criteria (4 listed)
- Being illiterate of reading and writing
- Having another orthopedic, neurological and cardiovascular problem
- Pre-existing complex regional pain syndrome
- Having had an operation involving the ipsilateral upper extremity in the last 6 months
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 |
|---|---|---|
| ExerciseAlso: Traditional Exercise ProgramIt is important for the therapist to organize a home exercise program to provide edema and pain control. The exercise program should be specific and clear to the patient. The exercise program will be taught to the patient and given as a home program | Other | Mulligan Mobilization Treatment, PNF Treatment Group |
| PNF TechniqueWhile the limb is in the agonist pattern, the patient is instructed to perform isometric contractions for 5-8 seconds against maximum resistance without movement at the limiting point. After maximum isometric contraction, the patient is instructed to actively relax.Participants in the second group will be applied 10 repetitions of isometric contractions for 8 seconds at the limitation points of the movement with the PNF techniques, the hold and relax active movement technique in the direction of wrist flexion and extension. | Other | PNF Treatment Group |
| Mulligan MobilizationIn thw Mobilization with movement technique; the patient is expected to perform painless ROM. After obtaining painless movement in the patients participating in the study, this application will be applied to the patient with the painless active movement technique in 10 repetitions and 2-3 sets. Rest time between sets will be 15-20 seconds. Patients will be taught self-mobilization to ensure the continuity of painless movement. Self-mobilization will be applied by the patient at home with 10 repetitions every two hours (29). | Other | Mulligan Mobilization Treatment |
Primary outcome
Pain Threshold Assessment
Time frame: 10 minutes
The pressure pain threshold in the wrist joint will be recorded by measuring with the Baseline Dolorimeter 66 pounds. In addition to subjective assessment methods, it is necessary to record before and after treatment using this device in order to evaluate pain more objectively and to be expressed in the literature as data with high scientific evidence level.
Visual Analog Scale
Time frame: 10 minutes
Visual Analog Scale (VAS) can be used to assess pain which perceived by patients. . VAS is a frequently used scale that indicates the severity of pain numerically. A 10 cm line is divided into 10 equal parts and both ends are numbered from 0 to 10 as the least and maximum pain intensity. Patients are asked to mark the place that best suits their pain intensity.
Muscle Strength Assessment
Time frame: 8 minutes
It is planned to use microFET®2 Digital Handheld Dynamometer device to evaluate the strength of wrist flexor and extensor muscles, ulnar and radial deviation muscles. The device has the feature of acquiring objective data and transferring it to a computer. Measurements are recorded in the range of 0-300 lbs. Measurements will be tested with 10 seconds of resistance in the muscle test position. The data of this device are needed to express the weakness in the wrist muscles after the distal radius end fracture as a quantitative value. Thus, the effectiveness of treatment programs can be compared by showing the effect of decreasing muscle strength.
Range of Motion Assessment (ROM)
Time frame: 10 minutes
The forearm and wrist joint range of motions will be performed with a universal goniometer in the patient sitting position and on the forearm examination table as degree. Evaluation will take place at weeks 6 and 12 (30-33).
Proprioception Assessment
Time frame: 8 minutes
The sensation of kinesthesia is measured by perceiving the minimum degree of motion of the joint per unit time and is generally used as the "passive motion detection threshold" in studies. Joint position sense; It is measured by the ability of a joint at a certain angle to actively or passively repeat the same position. As the error made while repeating the determined target angle decreases, the quality of the sense of joint position increases. Goniometer will be used for evaluation. The patients' deviations from the target angles for the wrist will be recorded as degree (33-37).
Tampa Kinesiophobia Scale
Time frame: 10 minutes
It will be used to assess kinesiophobia. The Tampa Kinesiophobia Scale is a self-report measure developed to assess the fear of movement-related pain in patients with musculoskeletal pain. Its items are grouped as activity avoidance and somatic focus, according to two different factors (38,39).The scale is scored with range from 1-4, the negatively worded items are 4,8,12,1 and having a reverse scoring (4-1). The 17 item total scores are ranged from 17 to 68 where the lowest 17 means no kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia
1 secondary outcome
Patient Rated Wrist Evaluation (PRWE)
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Results publication: PubMed 23200599Bruder AM, Taylor NF, Dodd KJ, Shields N. Physiotherapy intervention practice patterns used in rehabilitation after distal radial fracture. Physiotherapy. 2013 Sep;99(3):233-40. doi: 10.1016/j.physio.2012.09.003. Epub 2012 Nov 30.
- Results publication: PubMed 8856564Brown PW. Body and soul. J Hand Ther. 1996 Jul-Sep;9(3):201-2. doi: 10.1016/s0894-1130(96)80082-2. No abstract available.
- Results publication: PubMed 17768207Chen NC, Jupiter JB. Management of distal radial fractures. J Bone Joint Surg Am. 2007 Sep;89(9):2051-62. doi: 10.2106/JBJS.G.00020. No abstract available.
- Results publication: PubMed 23628557Karagiannopoulos C, Sitler M, Michlovitz S, Tierney R. A descriptive study on wrist and hand sensori-motor impairment and function following distal radius fracture intervention. J Hand Ther. 2013 Jul-Sep;26(3):204-14; quiz 215. doi: 10.1016/j.jht.2013.03.004. Epub 2013 Apr 28.
- Results publication: PubMed 1175109Cruess RL, Dumont J. Fracture healing. Can J Surg. 1975 Sep;18(5):403-13.
- Results publication: PubMed 6763662Frost HM. Mechanical determinants of bone modeling. Metab Bone Dis Relat Res. 1982;4(4):217-29. doi: 10.1016/0221-8747(82)90031-5.
- Results publication: PubMed 17560399Ilyas AM, Jupiter JB. Distal radius fractures--classification of treatment and indications for surgery. Orthop Clin North Am. 2007 Apr;38(2):167-73, v. doi: 10.1016/j.ocl.2007.01.002.
- Results publication: PubMed 28576135Jerrhag D, Englund M, Karlsson MK, Rosengren BE. Epidemiology and time trends of distal forearm fractures in adults - a study of 11.2 million person-years in Sweden. BMC Musculoskelet Disord. 2017 Jun 2;18(1):240. doi: 10.1186/s12891-017-1596-z.
- Results publication: PubMed 10882464Khan SN, Bostrom MP, Lane JM. Bone growth factors. Orthop Clin North Am. 2000 Jul;31(3):375-88. doi: 10.1016/s0030-5898(05)70157-7.
- Results publication: PubMed 12918866Youdas JW, Krause DA, Egan KS, Therneau TM, Laskowski ER. The effect of static stretching of the calf muscle-tendon unit on active ankle dorsiflexion range of motion. J Orthop Sports Phys Ther. 2003 Jul;33(7):408-17. doi: 10.2519/jospt.2003.33.7.408.
- Results publication: PubMed 17254909Schier JS, Chan J. Changes in life roles after hand injury. J Hand Ther. 2007 Jan-Mar;20(1):57-68; quiz 69. doi: 10.1197/j.jht.2006.10.005.
- Results publication: PubMed 23442339Safi A, Hart R, Teknedzjan B, Kozak T. Treatment of extra-articular and simple articular distal radial fractures with intramedullary nail versus volar locking plate. J Hand Surg Eur Vol. 2013 Sep;38(7):774-9. doi: 10.1177/1753193413478715. Epub 2013 Feb 26.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
İrem Guney, PT study chair
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, PNF Technique and Mulligan Mobilization in people with Distal Radius Fracture and Wrist Fracture, run by Biruni University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 13 Feb 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Threshold Assessment (time frame: 10 minutes). The study lists 6 primary outcomes in all. 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 NCT05883410, which also lists 18 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 13 Feb 2024.