Distal Radius FractureNCT05405023
Effects of Concentric Exercise With and Without Mulligan Wrist Mobilization After Distal Radius Fracture.
A study testing Concentric exercises with wrist mobilization and Concentric exercises without wrist mobilization in people with Distal Radius Fracture, run by Riphah International University at 1 site in Pakistan.
Trial summary
The distal end of the radius is defined as the area three centimeters proximal to the radio carpal joint, where the radius interfaces with the lunate and scaphoid bone of the wrist. A fracture of the distal radius is usually caused by falling on the outstretched arm. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Concentric exercises with wrist mobilization and Concentric exercises without wrist mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 27 May 2022to 27 Jan 2023
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 35-70 years
- Subjects with at least 6 weeks of distal radius fracture
- Orthopedic surgeon advise
Who cannot join
- Neurological problem affecting upper limb
- Parkinson disease
- Subjects having polyarthritis, bleeding disorders, tumors, local infection, peripheral vascular disease
- Any contraindication to physiotherapy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
DHQ Hospital Sheikhupura
Sheikhupura, Punjab Province, 39350
Saba Rafique, Phd*, +923034045433, saba.rafique@riphah.edu.pk
Iqra Shahzadi, MsPT (OMPT)
About this study
Official title: Effects of Concentric Exercise With and Without Mulligan Wrist Mobilization on Pain, Grip Strength, Range of Motion and Function After Distal Radius Fracture.
The distal end of the radius is defined as the area three centimeters proximal to the radio carpal joint, where the radius interfaces with the lunate and scaphoid bone of the wrist. A fracture of the distal radius is usually caused by falling on the outstretched arm. The majority of distal radial fractures are closed injuries in which the overlying skin remains intact. Pain, swelling, bruising, deformity and deformity in the forearm or wrist are common. In women, the incidence of distal radial fracture increases with age from 40 years. The objective of this study will be to determine the Effects of Concentric exercises with and without mulligan wrist mobilization on pain, grip strength, Range of motion and function after distal radius fracture.
This study will be a randomized controlled trial and will be conducted in District Head Quarter hospital sheikhupura. The study will be completed in time duration of six months after the approval of synopsis and convenience sampling technique will be used. 18 subjects will be divided in two groups. Group A will follow concentric exercises at wrist including flexion, extension, abduction, adduction, pronation, supination and wrist mobilizations with movements while group B will follow only wrist concentric exercises treatment. MWM based on Mulligan's Recommendation that the patient should not experience any pain. The Location and direction of the glide could be modified so that the MWM was pain free, as advocated in the Mulligan concept. This study will be of 4 weeks, 3 sessions per week. Data will be collected by all participants before 1st session after 6th session and at the end of 12th session by using NPRS, Hand Dynamometer, Goniometer and Patient Rated Wrist Evaluation score. Data will be analyzed by SPSS-25.
- Conditions
- Distal Radius Fracture
- Being tested
- Concentric exercises with wrist mobilization, Concentric exercises without wrist mobilization
- Keywords
- Disability, Range of Movement, Concentric exercises, Movement, Fracture
- Medical subject headings
- Wrist Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentric exercises with wrist mobilizationOther
Participants will receive concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation plus wrist mobilizations with movements.
Concentric exercises without wrist mobilizationOther
Participants will receive concentric exercises only.
| Study group | Role | What they receive |
|---|---|---|
| Concentric exercises with wrist mobilization | Experimental | concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation plus wrist mobilizations with movements Receives: Other: Concentric exercises with wrist mobilization |
| Concentric exercises without wrist mobilization | Active comparator | concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation Receives: Other: Concentric exercises without wrist mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist Pain
NPRS is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 4 weeks
Grip Strength
Handheld dynamometers are used for measuring grip strength. They are available in manual and digital version so there is a need to know the reliability of manual hand-held dynamometer and digital hand-held for measuring grip strength. Excellent reliability is found for manual and digital handheld dynamometers
Measured: 4 weeks
Range of motion
Goniometer is used to measure Range of motion. Hand-held pencil (HHP) and the plumb line goniometer (PLG) methods are used for measuring active forearm pronation and supination motions in individuals with and without injuries. The HHP and PLG are highly reliable methods for measuring functional forearm pronation and supination. Because plumb line goniometers are not commercially available and the instrumentation for the HHP method is readily accessible, clinicians should consider the latter as their method of choice for measuring functional forearm pronation and supination
Measured: 4 weeks
Wrist Function
For evaluating function Patient Rated Wrist Evaluation (PRWE) score is used. High-quality evidence supports the use of PRWE/PRWHE as a reliable, valid, and structurally sound questionnaire to assess pain and disability in patients with various wrist and hand injuries. The PRWE/PRWHE has been translated into 21 languages. High-quality evidence supports very good structural and cross-cultural validity, internal consistency, test-retest reliability, measurement error, and hypothesis testing for construct validity against DASH in wrist and hand injuries. However, low-quality evidence supports acceptable responsiveness property
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start27 May 2022 (estimated)
- Primary completion27 Nov 2022 (estimated)
- Study completion27 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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 Riphah International 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saba Rafique, Phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405023
- Sponsor's protocol ID
- REC/RCR&AHS/22/0128
- Status last verified
- May 2022
- First submitted
- 31 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meena S, Sharma P, Sambharia AK, Dawar A. Fractures of distal radius: an overview. J Family Med Prim Care. 2014 Oct-Dec;3(4):325-32. doi: 10.4103/2249-4863.148101.
PubMed 25657938Quadlbauer S, Pezzei C, Jurkowitsch J, Rosenauer R, Kolmayr B, Keuchel T, Simon D, Beer T, Hausner T, Leixnering M. Rehabilitation after distal radius fractures: is there a need for immobilization and physiotherapy? Arch Orthop Trauma Surg. 2020 May;140(5):651-663. doi: 10.1007/s00402-020-03367-w. Epub 2020 Mar 19.
PubMed 32193679Gutierrez-Espinoza H, Rubio-Oyarzun D, Olguin-Huerta C, Gutierrez-Monclus R, Pinto-Concha S, Gana-Hervias G. Supervised physical therapy vs home exercise program for patients with distal radius fracture: A single-blind randomized clinical study. J Hand Ther. 2017 Jul-Sep;30(3):242-252. doi: 10.1016/j.jht.2017.02.001. Epub 2017 Mar 22.
PubMed 28342739Gutierrez-Espinoza H, Araya-Quintanilla F, Olguin-Huerta C, Valenzuela-Fuenzalida J, Gutierrez-Monclus R, Moncada-Ramirez V. Effectiveness of manual therapy in patients with distal radius fracture: a systematic review and meta-analysis. J Man Manip Ther. 2022 Feb;30(1):33-45. doi: 10.1080/10669817.2021.1992090. Epub 2021 Oct 20.
PubMed 34668847Coughlin T, Norrish AR, Scammell BE, Matthews PA, Nightingale J, Ollivere BJ. Infographic: Comparison of rehabilitation interventions in nonoperatively treated distal radius fractures: a randomized controlled trial of effectiveness. Bone Joint J. 2021 Jun;103-B(6):1031-1032. doi: 10.1302/0301-620X.103B6.BJJ-2021-0729. No abstract available.
PubMed 34058884Gutierrez-Espinoza H, Araya-Quintanilla F, Olguin-Huerta C, Gutierrez-Monclus R, Jorquera-Aguilera R, Mathoulin C. Effectiveness of early versus delayed motion in patients with distal radius fracture treated with volar locking plate: A systematic review and meta-analysis. Hand Surg Rehabil. 2021 Feb;40(1):6-16. doi: 10.1016/j.hansur.2020.10.007. Epub 2020 Nov 2.
PubMed 33144249Tomruk M, Gelecek N, Basci O, Ozkan MH. Effects of early manual therapy on functional outcomes after volar plating of distal radius fractures: A randomized controlled trial. Hand Surg Rehabil. 2020 May;39(3):178-185. doi: 10.1016/j.hansur.2019.12.002. Epub 2020 Feb 15.
PubMed 32070793Reid 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 32291223Aguilera-Godoy A, Antunez-Riveros MA, Carrasco-Penna G, Nunez-Cortes R. A post-surgical rehabilitation program for women over 60 years old who underwent surgery in trauma and orthopedic hospital after distal radius fracture. J Bodyw Mov Ther. 2021 Oct;28:362-368. doi: 10.1016/j.jbmt.2021.07.042. Epub 2021 Aug 10.
PubMed 34776165Stathopoulos N, Dimitriadis Z, Koumantakis GA. Erratum to "Effectiveness of Mulligan's mobilization with movement techniques on pain and disability of peripheral joints: a systematic review with meta-analysis between 2008-2017" [Physiotherapy 105 (March (1)) (2019) 1-9]. Physiotherapy. 2020 Mar;106:219. doi: 10.1016/j.physio.2019.04.002. Epub 2019 Aug 30. No abstract available.
PubMed 31477334Shafiee E, MacDermid J, Farzad M, Karbalaei M. A systematic review and meta-analysis of Patient-Rated Wrist (and Hand) Evaluation (PRWE/PRWHE) measurement properties, translation, and/ or cross-cultural adaptation. Disabil Rehabil. 2022 Nov;44(22):6551-6565. doi: 10.1080/09638288.2021.1970250. Epub 2021 Sep 10.
PubMed 34505793
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Concentric Exercise With and Without Mulligan Wrist Mobilization on Pain, Grip Strength, Range of Motion and Function After Distal Radius Fracture.
- ClinicalTrials.gov ID
- NCT05405023
- Acronym / sponsor ID
- REC/RCR&AHS/22/0128
- Conditions
- Distal Radius Fracture
- Keywords
- Disability, Range of Movement, Concentric exercises, Movement, Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 27 May 2022 (estimated)
- Primary completion
- 27 Nov 2022 (estimated)
- Study completion
- 27 Jan 2023 (estimated)
- First posted
- 3 Jun 2022 (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.
The distal end of the radius is defined as the area three centimeters proximal to the radio carpal joint, where the radius interfaces with the lunate and scaphoid bone of the wrist. A fracture of the distal radius is usually caused by falling on the outstretched arm. The majority of distal radial fractures are closed injuries in which the overlying skin remains intact. Pain, swelling, bruising, deformity and deformity in the forearm or wrist are common. In women, the incidence of distal radial fracture increases with age from 40 years. The objective of this study will be to determine the Effects of Concentric exercises with and without mulligan wrist mobilization on pain, grip strength, Range of motion and function after distal radius fracture.
This study will be a randomized controlled trial and will be conducted in District Head Quarter hospital sheikhupura. The study will be completed in time duration of six months after the approval of synopsis and convenience sampling technique will be used. 18 subjects will be divided in two groups. Group A will follow concentric exercises at wrist including flexion, extension, abduction, adduction, pronation, supination and wrist mobilizations with movements while group B will follow only wrist concentric exercises treatment. MWM based on Mulligan's Recommendation that the patient should not experience any pain. The Location and direction of the glide could be modified so that the MWM was pain free, as advocated in the Mulligan concept. This study will be of 4 weeks, 3 sessions per week. Data will be collected by all participants before 1st session after 6th session and at the end of 12th session by using NPRS, Hand Dynamometer, Goniometer and Patient Rated Wrist Evaluation score. Data will be analyzed by SPSS-25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concentric exercises with wrist mobilization | Experimental | Other: Concentric exercises with wrist mobilizationconcentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation plus wrist mobilizations with movements |
| Concentric exercises without wrist mobilization | Active comparator | Other: Concentric exercises without wrist mobilizationconcentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 35-70 years
- Subjects with at least 6 weeks of distal radius fracture
- Orthopedic surgeon advise
Key exclusion criteria (4 listed)
- Neurological problem affecting upper limb
- Parkinson disease
- Subjects having polyarthritis, bleeding disorders, tumors, local infection, peripheral vascular disease
- Any contraindication to physiotherapy
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 |
|---|---|---|
| Concentric exercises with wrist mobilizationParticipants will receive concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation plus wrist mobilizations with movements. | Other | Concentric exercises with wrist mobilization |
| Concentric exercises without wrist mobilizationParticipants will receive concentric exercises only. | Other | Concentric exercises without wrist mobilization |
Primary outcome
Wrist Pain
Time frame: 4 weeks
NPRS is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Grip Strength
Time frame: 4 weeks
Handheld dynamometers are used for measuring grip strength. They are available in manual and digital version so there is a need to know the reliability of manual hand-held dynamometer and digital hand-held for measuring grip strength. Excellent reliability is found for manual and digital handheld dynamometers
Range of motion
Time frame: 4 weeks
Goniometer is used to measure Range of motion. Hand-held pencil (HHP) and the plumb line goniometer (PLG) methods are used for measuring active forearm pronation and supination motions in individuals with and without injuries. The HHP and PLG are highly reliable methods for measuring functional forearm pronation and supination. Because plumb line goniometers are not commercially available and the instrumentation for the HHP method is readily accessible, clinicians should consider the latter as their method of choice for measuring functional forearm pronation and supination
Wrist Function
Time frame: 4 weeks
For evaluating function Patient Rated Wrist Evaluation (PRWE) score is used. High-quality evidence supports the use of PRWE/PRWHE as a reliable, valid, and structurally sound questionnaire to assess pain and disability in patients with various wrist and hand injuries. The PRWE/PRWHE has been translated into 21 languages. High-quality evidence supports very good structural and cross-cultural validity, internal consistency, test-retest reliability, measurement error, and hypothesis testing for construct validity against DASH in wrist and hand injuries. However, low-quality evidence supports acceptable responsiveness property
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Background: PubMed 25657938Meena S, Sharma P, Sambharia AK, Dawar A. Fractures of distal radius: an overview. J Family Med Prim Care. 2014 Oct-Dec;3(4):325-32. doi: 10.4103/2249-4863.148101.
- Background: PubMed 32193679Quadlbauer S, Pezzei C, Jurkowitsch J, Rosenauer R, Kolmayr B, Keuchel T, Simon D, Beer T, Hausner T, Leixnering M. Rehabilitation after distal radius fractures: is there a need for immobilization and physiotherapy? Arch Orthop Trauma Surg. 2020 May;140(5):651-663. doi: 10.1007/s00402-020-03367-w. Epub 2020 Mar 19.
- Background: PubMed 28342739Gutierrez-Espinoza H, Rubio-Oyarzun D, Olguin-Huerta C, Gutierrez-Monclus R, Pinto-Concha S, Gana-Hervias G. Supervised physical therapy vs home exercise program for patients with distal radius fracture: A single-blind randomized clinical study. J Hand Ther. 2017 Jul-Sep;30(3):242-252. doi: 10.1016/j.jht.2017.02.001. Epub 2017 Mar 22.
- Background: PubMed 34668847Gutierrez-Espinoza H, Araya-Quintanilla F, Olguin-Huerta C, Valenzuela-Fuenzalida J, Gutierrez-Monclus R, Moncada-Ramirez V. Effectiveness of manual therapy in patients with distal radius fracture: a systematic review and meta-analysis. J Man Manip Ther. 2022 Feb;30(1):33-45. doi: 10.1080/10669817.2021.1992090. Epub 2021 Oct 20.
- Background: PubMed 34058884Coughlin T, Norrish AR, Scammell BE, Matthews PA, Nightingale J, Ollivere BJ. Infographic: Comparison of rehabilitation interventions in nonoperatively treated distal radius fractures: a randomized controlled trial of effectiveness. Bone Joint J. 2021 Jun;103-B(6):1031-1032. doi: 10.1302/0301-620X.103B6.BJJ-2021-0729. No abstract available.
- Background: PubMed 33144249Gutierrez-Espinoza H, Araya-Quintanilla F, Olguin-Huerta C, Gutierrez-Monclus R, Jorquera-Aguilera R, Mathoulin C. Effectiveness of early versus delayed motion in patients with distal radius fracture treated with volar locking plate: A systematic review and meta-analysis. Hand Surg Rehabil. 2021 Feb;40(1):6-16. doi: 10.1016/j.hansur.2020.10.007. Epub 2020 Nov 2.
- Background: PubMed 32070793Tomruk M, Gelecek N, Basci O, Ozkan MH. Effects of early manual therapy on functional outcomes after volar plating of distal radius fractures: A randomized controlled trial. Hand Surg Rehabil. 2020 May;39(3):178-185. doi: 10.1016/j.hansur.2019.12.002. Epub 2020 Feb 15.
- Background: PubMed 32291223Reid 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.
- Background: PubMed 34776165Aguilera-Godoy A, Antunez-Riveros MA, Carrasco-Penna G, Nunez-Cortes R. A post-surgical rehabilitation program for women over 60 years old who underwent surgery in trauma and orthopedic hospital after distal radius fracture. J Bodyw Mov Ther. 2021 Oct;28:362-368. doi: 10.1016/j.jbmt.2021.07.042. Epub 2021 Aug 10.
- Background: PubMed 31477334Stathopoulos N, Dimitriadis Z, Koumantakis GA. Erratum to "Effectiveness of Mulligan's mobilization with movement techniques on pain and disability of peripheral joints: a systematic review with meta-analysis between 2008-2017" [Physiotherapy 105 (March (1)) (2019) 1-9]. Physiotherapy. 2020 Mar;106:219. doi: 10.1016/j.physio.2019.04.002. Epub 2019 Aug 30. No abstract available.
- Background: PubMed 34505793Shafiee E, MacDermid J, Farzad M, Karbalaei M. A systematic review and meta-analysis of Patient-Rated Wrist (and Hand) Evaluation (PRWE/PRWHE) measurement properties, translation, and/ or cross-cultural adaptation. Disabil Rehabil. 2022 Nov;44(22):6551-6565. doi: 10.1080/09638288.2021.1970250. Epub 2021 Sep 10.
- 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.
Saba Rafique, Phd* principal investigator
Riphah International 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 Concentric exercises with wrist mobilization and Concentric exercises without wrist mobilization in people with Distal Radius Fracture, run by Riphah International University at 1 site in Pakistan.
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: status not confirmed, as of the sponsor's last update on 3 Jun 2022. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (+923324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrist Pain (time frame: 4 weeks). The study lists 4 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 NCT05405023, which also lists 11 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 3 Jun 2022.