ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625000820404

Ethics application status

Approved

Date submitted

29/05/2025

Date registered

31/07/2025

Date last updated

24/08/2025

Date data sharing statement initially provided

31/07/2025

Type of registration

Retrospectively registered

Titles & IDs

Public title

Comparative Analysis of Mulligan Mobilization with Movement (MWM) and Kaltenborn Mobilization: Evidence for Enhanced Elbow Recovery

Scientific title

Effectiveness of Kaltenborn and Mulligan mobilization with movement in post-traumatic rehabilitation patients.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1323-4873

Trial acronym

Post Traumatic Elbow Study - PTES

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post-Traumatic Elbow Stiffness

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1. Physical/Informational Materials Used
Hot packs (for actinotherapy) to promote tissue healing.
Goniometer for measuring elbow range of motion (ROM).
Treatment belt (for Mulligan’s MWM techniques).
Standardized assessment tools (Numeric Pain Rating Scale, Mayo Elbow Performance Score).
2. Procedures/Activities
Group B: Kaltenborn mobilization (radial/ulnar glides, 10 reps/session) + actinotherapy.
Group C: Mulligan’s MWM (medial/lateral glides, 3 sets × 10 reps/session) + actinotherapy.
All groups received pre-treatment actinotherapy for pain relief and tissue preparation.
3. Adherence Assessment
Session attendance recorded for each participant.
Treatment logs documented by the physiotherapist (e.g., reps/sets completed, heat application duration).
Standardized tools (NPRS, MEPS) administered pre/post-intervention to monitor progress.
4. Group Allocation
Determined by physician discretion based on clinical presentation (e.g., pain severity, ROM limitations).
5. Intervention Provider
Licensed physiotherapist with expertise in manual therapy, following standardized protocols.
6. Mode of Delivery
Face-to-face, individual sessions.
Location: Outpatient Physiotherapy Department.
7. Duration/Frequency
10 sessions (5 sessions/week for 2 weeks).
Each session: 30–45 minutes (actinotherapy + mobilization/exercises).
8. Location
Outpatient Physiotherapy Department, Independent University Hospital, Faisalabad, Pakistan.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Group A: Active Range of Motion (A-ROM) Exercises + Actinotherapy
Purpose: Served as the active control to compare the efficacy of Kaltenborn mobilization and Mulligan’s MWM against standard rehabilitation.
1. Intensity Level
Low to moderate intensity:
Assessment Method:
Borg Scale (RPE 3–5/10) for perceived exertion.
Heart rate monitoring (60–75% of age-predicted max) during exercises.
Pain thresholds monitored via Numeric Pain Rating Scale (e.g: score of NPRS is 3 out of 10 during activity).
2. Example Exercises
Elbow flexion/extension:
Seated, with forearm supported; slow, controlled motion within pain-free ROM.
Dose: 3 sets × 10 reps/session.
Forearm supination/pronation:
Holding a lightweight (0.5–1 kg) dowel; emphasis on smooth movement.
3. Adjunctive Intervention
Actinotherapy: Hot packs applied for 10 minutes/session pre-exercise to reduce pain/stiffness.
4. Dose/Duration
Frequency: 5 sessions/week for 2 weeks (total 10 sessions).
Session duration: 30–45 minutes (including actinotherapy + A-ROM).
5. Rationale for Control Selection
Represents conventional rehabilitation for elbow dysfunction, allowing isolation of experimental effects (Kaltenborn/Mulligan’s added value).

Control group

Active

Outcomes

Primary outcome [1]

Range of Motion of the elbow joint

Timepoint [1]

Baseline (pre-intervention), Post-intervention (immediately after the 2-week treatment period)

Secondary outcome [1]

Pain intensity

Timepoint [1]

Baseline, Post-intervention (after 2-week treatment period)

Secondary outcome [2]

Elbow joint function

Timepoint [2]

Baseline, Post-intervention (after 2-week treatment period)

Secondary outcome [3]

Muscle strength

Timepoint [3]

Baseline, Post-intervention (after 2-week treatment period)

Eligibility

Key inclusion criteria

Patients clinically diagnosed with post-traumatic elbow stiffness persisting for 4-6 months

Age range: 10-40 years (all genders included)

Medically stable and eligible for manual therapy interventions

Limited elbow range of motion (ROM) confirmed by goniometric assessment

Willing and able to provide informed consent (or parental consent for minors)

No systemic illnesses or metabolic conditions affecting musculoskeletal health

No other concurrent musculoskeletal disorders in the affected limb

Clinically stable fracture union (if stiffness resulted from fracture)

No contraindications to physiotherapy interventions (e.g., acute inflammation, infections)

No cognitive impairments affecting ability to follow treatment protocols

Minimum age

10 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Systemic illnesses (e.g., diabetes, rheumatoid arthritis) affecting musculoskeletal healing

Metabolic bone disorders (e.g., osteoporosis)

Acute fractures or non-union fractures in the affected elbow

History of elbow joint replacement or surgical fixation in the last 6 months

Neurological conditions (e.g., nerve injuries, radiculopathy) contributing to stiffness

Active infections or inflammatory conditions in the elbow region

Severe osteoarthritis or degenerative joint disease in the elbow

Cognitive impairments limiting ability to follow treatment protocols

Contraindications to manual therapy (e.g., malignancy, vascular compromise)

Participation in another concurrent rehabilitation program for the same condition

Allergies or adverse reactions to actinotherapy (hot packs)

Unwillingness to comply with the study protocol or attend all sessions

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

10/09/2024

Date of last participant enrolment

Anticipated

Actual

25/02/2025

Date of last data collection

Anticipated

Actual

11/03/2025

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

Punjab

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr, Mehlaqa Waseem

Address [1]

Country [1]

Pakistan

Primary sponsor type

Individual

Name

Dr. Mehlaqa Waseem- Independent University Hospital, Faisalabad

Address

Country

Pakistan

Secondary sponsor category [1]

Individual

Name [1]

Dr. Arslan Iftikhar- Government College University, Faisalabad

Address [1]

Country [1]

Pakistan

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Institutional Review Board

Ethics committee address [1]

41-2617122-24

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

01/09/2024

Approval date [1]

12/11/2024

Ethics approval number [1]

Summary

Brief summary

This study tested whether two advanced physiotherapy techniques, Kaltenborn mobilization and Mulligan’s Mobilization with Movement (MWM), work better than standard exercises to improve elbow stiffness after injury. Forty-five patients received either standard exercises, Kaltenborn, or Mulligan’s techniques combined with heat therapy for 2 weeks, with progress tracked through pain and mobility measurements. We hypothesized that Mulligan’s MWM would show superior results in restoring pain-free elbow movement compared to other methods. Treatments were delivered by licensed physiotherapists in a hospital outpatient setting.

Trial website

Trial related presentations / publications

Public notes

We had submitted the ethics approval application prior to the enrollment of the first participant. However, due to an administrative oversight at the institute, our submitted file was misplaced, which delayed the formal approval process. We sincerely regret this error and confirm that all ethical considerations were adhered to during the study.

Contacts

Principal investigator

Name

Dr Nehal Fatima

Address

Independent University Hospital Marzipura, Kothi Sadat C2RF+FP6, Faisalabad, Punjab

Country

Pakistan

Phone

+92 312 1238927

Fax

[email protected]

Contact person for public queries

Name

Mehlaqa Waseem

Address

Independent University Hospital Marzipura, Kothi Sadat C2RF+FP6, Faisalabad, Punjab

Country

Pakistan

Phone

+92 335 8603666

Fax

[email protected]

Contact person for scientific queries

Name

Mehlaqa Waseem

Address

Independent University Hospital Marzipura, Kothi Sadat C2RF+FP6, Faisalabad, Punjab

Country

Pakistan

Phone

+92 335 8603666

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements

What individual participant data might be shared?

• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data

What types of analyses could be done with individual participant data?

• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Teaching research methods or developing new statistical techniques

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
No end date

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: Email: [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Ethical approval					Ethical.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically