NCT05883410

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

April 13, 2023

Last Update Submit

February 12, 2024

Conditions

Keywords

Distal Radius FracturesJoint LimitationMulligan MobilizationPNF TechniqueProprioception

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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).

    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).

    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

    10 minutes

Secondary Outcomes (1)

  • Patient Rated Wrist Evaluation (PRWE)

    10 minutes

Study Arms (2)

PNF Treatment Group

EXPERIMENTAL

Hold-relax is a PNF technique will be applied to this group.

Other: ExerciseOther: PNF Technique

Mulligan Mobilization Treatment

ACTIVE COMPARATOR

The Mobilization with movement (MWM) technique will be applied to this group.

Other: ExerciseOther: Mulligan Mobilization

Interventions

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

Also known as: Traditional Exercise Program
Mulligan Mobilization TreatmentPNF Treatment Group

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.

PNF Treatment Group

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).

Mulligan Mobilization Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (18)

  • 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.

  • Brown 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.

  • Chen 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.

  • Karagiannopoulos 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.

  • Cruess RL, Dumont J. Fracture healing. Can J Surg. 1975 Sep;18(5):403-13.

  • Frost HM. Mechanical determinants of bone modeling. Metab Bone Dis Relat Res. 1982;4(4):217-29. doi: 10.1016/0221-8747(82)90031-5.

  • Ilyas 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.

  • Jerrhag 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.

  • Khan 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.

  • Youdas 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.

  • Schier 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.

  • Safi 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.

  • Reyhan 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.

  • Reid 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.

  • de Palma L, Tulli A, Maccauro G, Sabetta SP, del Torto M. Fracture callus in osteopetrosis. Clin Orthop Relat Res. 1994 Nov;(308):85-9.

  • Ozaki A, Tsunoda M, Kinoshita S, Saura R. Role of fracture hematoma and periosteum during fracture healing in rats: interaction of fracture hematoma and the periosteum in the initial step of the healing process. J Orthop Sci. 2000;5(1):64-70. doi: 10.1007/s007760050010.

  • Noordeen MH, Lavy CB, Shergill NS, Tuite JD, Jackson AM. Cyclical micromovement and fracture healing. J Bone Joint Surg Br. 1995 Jul;77(4):645-8.

  • Melton LJ 3rd, Amadio PC, Crowson CS, O'Fallon WM. Long-term trends in the incidence of distal forearm fractures. Osteoporos Int. 1998;8(4):341-8. doi: 10.1007/s001980050073.

MeSH Terms

Conditions

Wrist Fractures

Interventions

Exercise

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • İrem Guney, PT

    Biruni University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants does not know which type of treatment is received themselves.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Physiotherapist

Study Record Dates

First Submitted

April 13, 2023

First Posted

June 1, 2023

Study Start

May 30, 2023

Primary Completion

July 15, 2023

Study Completion

January 25, 2024

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations