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The use of manual therapy as an adjunct to physiotherapy for persistent shoulder pain: a feasibility study

The effectiveness of manual therapy with individualised multi-modal physiotherapy for rotator cuff related shoulder pain (RCRSP): a pilot randomized, non-inferiority controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000034639
Enrollment
70
Registered
2023-01-12
Start date
2023-05-24
Completion date
2023-11-29
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of this pilot RCT is to determine the feasibility, adherence, and treatment fidelity and adverse responses for a full RCT evaluating whether multi-modal physiotherapy without manual therapy (No Manual therapy group) is as effective as multi-modal physiotherapy with manual therapy (Manual therapy group). The second aim will be to determine preliminary estimates of treatment effects for patient-reported function, pain, self-efficacy and satisfaction. The third aim is to explore patient perspectives and experiences of the interventions and of the research process. This will be a two-arm, single-blinded pilot randomised clinical trial using a non-inferiority design. We hypothesise that there will not be a difference in primary outcome (QuickDASH) at 3 months and 6 months after entry into the study.

Interventions

Participants of the Manual Therapy Group will receive up to 8 physiotherapy sessions within a 3-month period. Two of the sessions will be one hour duration, and the remaining sessions will be half-hour. The weekly frequency will vary, negotiated individually between the physiotherapist and the patient. Patients will receive manual therapy, exercise prescription, patient education and guidance for physical activity during the 8 sessions. Manual therapy will be applied for at least 4 of the 8 ses

Participants of the Manual Therapy Group will receive up to 8 physiotherapy sessions within a 3-month period. Two of the sessions will be one hour duration, and the remaining sessions will be half-hour. The weekly frequency will vary, negotiated individually between the physiotherapist and the patient. Patients will receive manual therapy, exercise prescription, patient education and guidance for physical activity during the 8 sessions. Manual therapy will be applied for at least 4 of the 8 sessions using a pragmatic approach based on clinical reasoning. The techniques may include the following: • Passive joint mobilisations (Maitland concept) • Mobilisations-with-movement (Mulligan concept) • The symptom-modification approach (Lewis) • Thoracic manipulations • Soft tissue mobilisations of the cervical spine, axio-scapular and glenohumeral muscles. Techniques will be based on the patient’s specific impairments (e.g. loss of range of movement or pain during a specific movement) and their functional goals. The dosage will be dependent on the pain intensity and the patient’s tolerance. Considerations will be the starting position (e.g. supine or prone, and angle of the arm), the direction of the mobilisation, and the grade of the oscillatory mobilisation [‘depth’ and amplitude]. For the Mulligan and symptom-modification approaches, articular glides that reduce the patient’s pain during a specific movement will be applied. The glides will be applied either manually (physiotherapist’s hands) or with a manual therapy belt, during 6 to 8 repetitions of the active movement. Progressions will be based on the patient’s pain/symptom responses immediately after the application (within session) and on return for the next appointment (between sessions). A. What (materials) Patient education: Guided by resources developed and collated by the research team: • Website https://shoulderpain.org.nz/ • Set of two Microsoft® Powerpoint files developed by the research team – (1) pain neurophysiology; (2) reasons for undertaking exercise and physical activity. Exercise prescription: Strength training equipment (free weights, resistance bands). Patient diaries to document goals; progress; physical activity and exercise; pain medication; visits to other health professionals; direct and indirect treatment costs. Belts used for mobilisations-with-movement. B. What (procedures): Communication, advice and education The physiotherapist will use a person-centered approach, using a culturally responsive approach to explore the patient’s pain experience, goals and devising a rehabilitation plan; motivational interviewing and reflective listening. Websites and Powerpoint files will guide provision of information. Topic sequencing will be individualised to each patient. The therapist will send a link to applicable videos to patients who will be able to watch them as often as they find helpful. Topics: • Anatomy of the shoulder Surface anatomy of trapezius, deltoid, biceps and triceps muscles; rotator cuff; tendinopathy, partial and full tear; common age-related changes of the rotator cuff. https://shoulderpain.org.nz/your-shoulder/shoulder-anatomy • Connecting with our nervous system The messenger system: neurons, nervous system; the alarm system: sensitivity of the nervous system; factors influencing the alarm system and pain; patterns in the brain (‘neurotags’); factors influenced by the ‘alarm system’ (stress, memory, sleep, concentration, digestion, immunity). https://youtu.be/yw0NCIb73Bc https://shoulderpain.org.nz/pain-management/pain-types-and-causes • Managing shoulder pain and wellness with movement: exercise and general physical activity Role of exercise and physical activity towards general health and wellness and desensitising the nervous system; role of specific exercises to strengthen the shoulder; pacing, ‘walking the line’. https://youtu.be/Ucao9wcl81Y Exercise prescription Exercises are designed to progressively load the shoulder and to promote general physical activity. We will follow the following processes: Stage 1: Early stage rehabilitation and shoulder symptom modification Low-level exercises (motor control exercises), slow, controlled movements, focussing on quality. Stage 2: Eccentric and heavy slow resistance exercises Progress shoulder-specific exercises using the Shape-Up-My-Shoulder (SUMS) approach considering potential variables such as increasing range, load (weight), frequency, speed. Stage 3: Functional programme Progressively returning to function in terms of individual-specific work, sports, daily activities and recreation. This phase overlaps with Stage 1 and 2, and consists of a general exercise programme, including general physical activity. The programme is individualised to the patient’s requirements and goals, and progressed C. Providers The intervention will be provided by registered physiotherapists (any experience level). They will be trained by the researchers at a one-day workshop, within the month prior to start of recruitment. The Health Psychology researcher (Swain) will train the clinicians for the therapeutic relationship/cognitive skills. Follow-up sessions will be held with the principal investigator via Zoom or in person. D. How Face-to-face physiotherapy care and self-directed home exercises. E. Where University of Otago School of Physiotherapy clinics, Dunedin and Christchurch, New Zealand. F. When and how much Recruitment is planned from February to August 2023. Physiotherapy care will be provided with up to 8 sessions across a three-month period: two of them will be one hour, and the remaining ones ½-hour duration. The frequency of the sessions across the three-month period will be based on the physiotherapist’s and patients’ collaborative decision. G. Tailoring A pragmatic approach will be used, tailored to the patients’ clinical presentation and approach. Education: sequencing of information provided to the patient will be dependent on the line of the conversations and questions asked by the patient. Exercise prescription: Starting dosage of exercises will be dependent on the assessment of their ability and tolerance during specific exercises. The load (weight), repetitions, sets and frequency will be assessed to be within the patient’s tolerance of discomfort/pain. In general, exercises will be prescribed with 15 repetitions with 2 or 3 sets on a daily basis. Progression will include the number of exercises (1 exercise to up to 6 exercises), body starting position, load, number of repetitions/sets/frequency, and speed. Prescription of general physical activity (e.g. walking) will also be based on the patient’s interest, past activity level, as well as current tolerance, for example, walking 15 minutes daily. H. Modifications Any modifications to the protocol will be documented and reported. I. Safety • Physical risks may include delayed onset muscle soreness (muscle stiffness) as a normal consequence of exercise. Participants will be asked to record these in their diary and report back to the physiotherapist. The physiotherapist will be asked to record the symptoms in their clinical notes. Exercises will be modified if the muscle stiffness is considered excessive by the participant. • Exercise or manual therapy may also flare up pain. The physiotherapist will discuss with the participant what level of discomfort or pain might be expected during the exercises. In most cases such exercise-related discomfort/pain settles within 24 hours. If it lasts longer than 24 hours and the participant considers the discomfort/pain excessive, they will be asked to avoid the specific exercise and report that back to the physiotherapist. The Physiotherapist will record such response in the clinical notes, and modify the exercises at a lower intensity. • Manual Therapy: there may be discomfort and pain during the application of manual therapy. The physiotherapist will continuously ask the participant to report such discomfort while applying the technique. Their response immediately following application will be assessed, following routine physiotherapy processes. The participant will be asked to report back at the next session what the symptom response following the treatment was. The physiotherapist will record their self-reported response, and will modify manual therapy applications accordingly.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
35 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion criteria will be: (i) men and women, aged 35 years and older; (ii) primary complaint of shoulder pain with or without referral in the upper limb for a minimum of 3 months, (iii) shoulder pain attributed to a RCRSP using the diagnostic guidelines of the British Elbow and Shoulder Society (BESS). The middle aged and older adults are included as those are more likely to have recurrent or persistent RCRSP than younger adults.

Exclusion criteria

Exclusion criteria will be: (i) any shoulder surgery in the past, (ii) known systemic inflammatory disorders, (iii) cervical repeated movement testing affecting shoulder pain and/or range of movement, (iv) severe depressive symptoms, suicidal or psychotic illness (PHQ-9, score >23).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026