PainNCT05976724
Mobilization With Movement in Distal Radial Fractures
A study testing TENS, exercise and Mulligan mobilisation in people with Pain and Acute Pain, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Distal radius fractures (DRF) are the most common upper extremity disorders encountered in clinical practice. With an understanding of the mechanics of distal radius fractures, surgical intervention, and bone healing, the therapist can modify the therapy program according to the patient's individual needs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Acute Pain, Mobility Limitation
- What is being tested?
- TENS, exercise and Mulligan mobilisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 13 Nov 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with distal radius fracture
Who cannot join
- Patients with polytrauma,
- open fracture,
- ulnar head fracture (excluding ulnar styloid fracture),
- history of complex regional pain syndrome,
- limited cognitive capacity were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Movement With Mobilization Technique for Distal Radial Fractures
Distal radius fractures (DRF) are the most common upper extremity disorders encountered in clinical practice. With an understanding of the mechanics of distal radius fractures, surgical intervention, and bone healing, the therapist can modify the therapy program according to the patient's individual needs. The therapeutic process is begun in the crucial stage of bone healing during fracture immobilization. By addressing edema reduction and early range of motion of the uninvolved joints, most problems can be avoided before cast or fixator removal. Rehabilitation following the immobilization period should focus on regaining wrist movements provided that earlier problems have been addressed properly. During the rehabilitative process, the therapist can incorporate scar management, modalities, joint mobilization, active and passive range of motion, splinting, and strengthening to maximize the patient's functional result.
Massage and mobilization techniques are used in the treatment of DRF due to their analgesic effects. The painless mobilization with movement technique (MWM, developed by Brian Mulligan) is a manual therapy method applies to correct the limitation of movement in the joint and to relieve pain and functional disorders. Many studies have shown that MWM technique provides faster and momentary painless joint movement compared to other physical therapy modalities. The patient group with DRF has a large place in the general population and long treatment processes cause both labour loss and economic loss. Therefore, this study aimed to examine the effectiveness of MWM technique in cases with distal radius fractures.
Read the detailed description
In this study, 42 DRF patients with age range 18-65 who applied to Kırşehir Ahi Evran University Training and Research Hospital were examined. The individuals included in the study were divided into two groups according to the paired randomization method. These groups were control and intervention groups. Traditional physiotherapy methods were applied to the control group, traditional physiotherapy and MWM techniques were applied to the intervention group. Traditional physiotherapy methods were included; Transcutaneous Electrical Nerve Stimulation (TENS), stretching and strengthening exercises.
For the evaluation of patients; Visual Analogue Scale (VAS), wrist goniometric measurements, grip strength measurement, pinch strength measurement, edema measurement and Munich Wrist Questionnaire (MWQ) were used.
- Conditions
- Pain, Acute Pain, Mobility Limitation
- Being tested
- TENS, exercise, Mulligan mobilisation
- Keywords
- Pain, Range of motion
- Medical subject headings
- Pain, Acute Pain, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS, exerciseOther
TENS: The patients were sat in a chair positioned next to a treatment table. The hand to be treated was placed on the treatment table with the forearm in the supine position. Electrodes were then placed on the transverse carpal ligament and palmar surface of the hand. Conventional TENS was applied, with the current transition time set to 50-100 µs, and performed at a frequency of 100 Hz for a period of 20 minutes at an amplitude that did not cause muscle contraction or any feeling of numbness or tingling.
The supervised exercises were performed by the patients in a seated position. Strengthening exercises were performed with both hands by means of Digi-Flex hand exerciser (IMC Products Corp, Hicksville, New York), modeling mass and elastics. The patients were tasked with performing these exercises 10 times in each session and three times daily.
Mulligan mobilisationOther
Each participant was tested with sustained manual glides in each of the possible directions during active wrist flexion and extension from the seated position. For the lateral glide, the therapist stabilises the lateral aspect of the distal radius using the first web-space. And glides the proximal row of carpal bones laterally (towards the thumb) using the first web-space of the other hand, following the joint line. For the medial glide, the therapist stabilises the medial aspect of the distal ulna using the first web-space. And glides the proximal row of carpal bones medially (away from the thumb) using the first web-space of the other hand, following the joint line.
| Study group | Role | What they receive |
|---|---|---|
| Mobilization with movement | Experimental | Mobilization with movement technique and traditional physiotherapy will be applied to the intervention group. Also patients will receive a traditional therapy program consisting of Conventional TENS and stretching and strengthening exercises. Receives: Other: TENS, exercise; Other: Mulligan mobilisation |
| Control group | Active comparator | Patients will receive a traditional therapy program consisting of Conventional TENS and stretching and strengthening exercises. Receives: Other: TENS, exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS). As a simple and commonly applied method, VAS is considered to be both valid and reliable in measuring patient pain intensity. The patients in the current study were each asked with indicating the intensity of their pain experienced within the past 24 hours by marking on a 10-cm line scale, where 0 = "No pain" and 10 = "Maximum pain
Measured: 0-5 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Aug 2023
- Primary completion10 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İSMAİL CEYLAN, Ahi Evran University Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976724
- Sponsor's protocol ID
- 12068451744
- Status last verified
- Nov 2023
- First submitted
- 26 Jun 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beselga C, Neto F, Alburquerque-Sendin F, Hall T, Oliveira-Campelo N. Immediate effects of hip mobilization with movement in patients with hip osteoarthritis: A randomised controlled trial. Man Ther. 2016 Apr;22:80-5. doi: 10.1016/j.math.2015.10.007. Epub 2015 Oct 31.
PubMed 26559319Cruz-Diaz D, Lomas Vega R, Osuna-Perez MC, Hita-Contreras F, Martinez-Amat A. Effects of joint mobilization on chronic ankle instability: a randomized controlled trial. Disabil Rehabil. 2015;37(7):601-10. doi: 10.3109/09638288.2014.935877. Epub 2014 Jul 3.
PubMed 24989067
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Movement With Mobilization Technique for Distal Radial Fractures
- ClinicalTrials.gov ID
- NCT05976724
- Acronym / sponsor ID
- 12068451744
- Conditions
- Pain, Acute Pain, Mobility Limitation
- Keywords
- Pain, Range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 4 Aug 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 (DRF) are the most common upper extremity disorders encountered in clinical practice. With an understanding of the mechanics of distal radius fractures, surgical intervention, and bone healing, the therapist can modify the therapy program according to the patient's individual needs. The therapeutic process is begun in the crucial stage of bone healing during fracture immobilization. By addressing edema reduction and early range of motion of the uninvolved joints, most problems can be avoided before cast or fixator removal. Rehabilitation following the immobilization period should focus on regaining wrist movements provided that earlier problems have been addressed properly. During the rehabilitative process, the therapist can incorporate scar management, modalities, joint mobilization, active and passive range of motion, splinting, and strengthening to maximize the patient's functional result.
Massage and mobilization techniques are used in the treatment of DRF due to their analgesic effects. The painless mobilization with movement technique (MWM, developed by Brian Mulligan) is a manual therapy method applies to correct the limitation of movement in the joint and to relieve pain and functional disorders. Many studies have shown that MWM technique provides faster and momentary painless joint movement compared to other physical therapy modalities. The patient group with DRF has a large place in the general population and long treatment processes cause both labour loss and economic loss. Therefore, this study aimed to examine the effectiveness of MWM technique in cases with distal radius fractures.
Detailed description
In this study, 42 DRF patients with age range 18-65 who applied to Kırşehir Ahi Evran University Training and Research Hospital were examined. The individuals included in the study were divided into two groups according to the paired randomization method. These groups were control and intervention groups. Traditional physiotherapy methods were applied to the control group, traditional physiotherapy and MWM techniques were applied to the intervention group. Traditional physiotherapy methods were included; Transcutaneous Electrical Nerve Stimulation (TENS), stretching and strengthening exercises.
For the evaluation of patients; Visual Analogue Scale (VAS), wrist goniometric measurements, grip strength measurement, pinch strength measurement, edema measurement and Munich Wrist Questionnaire (MWQ) were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Mobilization with movement | Experimental | Other: TENS, exercise, Other: Mulligan mobilisationMobilization with movement technique and traditional physiotherapy will be applied to the intervention group. Also patients will receive a traditional therapy program consisting of Conventional TENS and stretching and strengthening exercises. |
| Control group | Active comparator | Other: TENS, exercisePatients will receive a traditional therapy program consisting of Conventional TENS and stretching and strengthening exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with distal radius fracture
Key exclusion criteria (5 listed)
- Patients with polytrauma,
- open fracture,
- ulnar head fracture (excluding ulnar styloid fracture),
- history of complex regional pain syndrome,
- limited cognitive capacity were excluded
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 |
|---|---|---|
| TENS, exerciseTENS: The patients were sat in a chair positioned next to a treatment table. The hand to be treated was placed on the treatment table with the forearm in the supine position. Electrodes were then placed on the transverse carpal ligament and palmar surface of the hand. Conventional TENS was applied, with the current transition time set to 50-100 µs, and performed at a frequency of 100 Hz for a period of 20 minutes at an amplitude that did not cause muscle contraction or any feeling of numbness or tingling. The supervised exercises were performed by the patients in a seated position. Strengthening exercises were performed with both hands by means of Digi-Flex hand exerciser (IMC Products Corp, Hicksville, New York), modeling mass and elastics. The patients were tasked with performing these exercises 10 times in each session and three times daily. | Other | Control group, Mobilization with movement |
| Mulligan mobilisationEach participant was tested with sustained manual glides in each of the possible directions during active wrist flexion and extension from the seated position. For the lateral glide, the therapist stabilises the lateral aspect of the distal radius using the first web-space. And glides the proximal row of carpal bones laterally (towards the thumb) using the first web-space of the other hand, following the joint line. For the medial glide, the therapist stabilises the medial aspect of the distal ulna using the first web-space. And glides the proximal row of carpal bones medially (away from the thumb) using the first web-space of the other hand, following the joint line. | Other | Mobilization with movement |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 0-5 week
Visual Analogue Scale (VAS). As a simple and commonly applied method, VAS is considered to be both valid and reliable in measuring patient pain intensity. The patients in the current study were each asked with indicating the intensity of their pain experienced within the past 24 hours by marking on a 10-cm line scale, where 0 = "No pain" and 10 = "Maximum pain
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 15 Nov 2023.
- Results publication: PubMed 26559319Beselga C, Neto F, Alburquerque-Sendin F, Hall T, Oliveira-Campelo N. Immediate effects of hip mobilization with movement in patients with hip osteoarthritis: A randomised controlled trial. Man Ther. 2016 Apr;22:80-5. doi: 10.1016/j.math.2015.10.007. Epub 2015 Oct 31.
- Results publication: PubMed 24989067Cruz-Diaz D, Lomas Vega R, Osuna-Perez MC, Hita-Contreras F, Martinez-Amat A. Effects of joint mobilization on chronic ankle instability: a randomized controlled trial. Disabil Rehabil. 2015;37(7):601-10. doi: 10.3109/09638288.2014.935877. Epub 2014 Jul 3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS, exercise and Mulligan mobilisation in people with Pain and Acute Pain, run by Ahi Evran University Education and Research Hospital 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 1 inclusion and 5 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 15 Nov 2023. 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?
Visual Analogue Scale (VAS) (time frame: 0-5 week). 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 NCT05976724, which also lists 2 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 15 Nov 2023.