Mulligan Mobilisation with Movement vs Conventional Physiotherapy in Adhesive Capsulitis: An RCT

Adhesive capsulitis — frozen shoulder — is one of the commonest referrals in Indian orthopaedic outpatient departments, with a particularly high burden among middle-aged adults and people with diabetes. It resolves slowly over months to years, and treatment choices are driven as much by local practice as by evidence: some clinicians favour sustained natural apophyseal glides in the Mulligan style, others graded passive mobilisation plus stretching. Both camps claim better and faster results; Indian head-to-head trials with validated outcome measures are scarce.

This MPT dissertation is a two-group randomised controlled trial comparing Mulligan Mobilisation-With-Movement (MWM) — pain-free sustained accessory glides applied with a mobilisation belt while the patient actively moves through flexion, abduction or external rotation, with overpressure — against a conventional physiotherapy programme of Maitland-grade passive glides, hot pack, pendular and capsular stretching exercises. Both groups receive 6 weeks of thrice-weekly treatment.

Outcomes are measured at baseline, week 3 and week 6 by a blinded assessor: the primary outcome is the Shoulder Pain and Disability Index (SPADI); secondary outcomes are the Numeric Pain Rating Scale (NPRS) and goniometric passive range of motion in flexion, abduction and external rotation. Sample size is computed in G*Power, the protocol is approved by the Institutional Ethics Committee and registered on CTRI before enrolment, and all data are handled in coded, anonymised form under the ICMR National Ethical Guidelines (2017). The study follows the MPT synopsis → ethics approval → dissertation → viva route used by RGUHS, KUHS and MUHS.

Frozen shoulder affects a large working-age population in India, particularly people with diabetes, and disproportionately disrupts occupations that need overhead reach — farmers, electricians, tailors, drivers. Clinics treat it with one manual-therapy school or another based on training and anecdote rather than local evidence: comparative trials with validated shoulder-specific outcomes, blinded assessment and prospective registration are scarce in Indian settings, so neither the relative effect of Mulligan MWM against conventional mobilisation-plus-exercise nor the pace of improvement over a realistic 6-week course is known locally.

This dissertation therefore asks: in adults with adhesive capsulitis in the stiffness phase, does 6 weeks of Mulligan Mobilisation-With-Movement produce greater improvement in SPADI, NPRS and passive shoulder ROM than conventional physiotherapy — and are the gains clinically meaningful rather than merely statistically significant?

Abstract

Background: Adhesive capsulitis causes pain and progressive loss of shoulder motion, affecting dressing, work and sleep, and runs a course of one to three years if left to resolve naturally. Manual therapy is widely used, but the two dominant schools — Mulligan's MWM and conventional graded passive mobilisation with exercise — have rarely been compared in Indian populations using validated, self-report outcomes. Aim: To compare the effectiveness of Mulligan MWM and conventional physiotherapy on pain, disability and passive range of motion in adults with adhesive capsulitis in the stiffness phase. Methods: Two-arm parallel-group randomised controlled trial; 52 participants; 6 weeks of treatment, three sessions per week; SPADI, NPRS and goniometric ROM measured at baseline, week 3 and week 6; analysis by repeated-measures ANOVA.

Introduction

Adhesive capsulitis is characterised by gradual restriction of active and passive motion, with external rotation typically limited earliest, a global capsular pattern, and absence of a major traumatic cause. It is classified into freezing, stiffness (adhesive) and thawing phases; the stiffness phase, where pain is settling but restriction dominates, is the window in which manual therapy is most commonly applied. In India the association with diabetes mellitus makes the condition both more prevalent and more persistent, which is why glycaemic status is recorded and balanced in this trial.

Review of literature and gap

A published randomised trial (Doner and colleagues, 2013) found Mulligan's technique comparable to passive stretching in restoring motion and function, and systematic reviews of manual therapy in frozen shoulder report short-term benefit as an adjunct to exercise. However, many available trials use heterogeneous comparator treatments, unvalidated outcome instruments or single-group pre–post designs, and few report SPADI — a shoulder-specific index with published reliability evidence — as the primary outcome. Indian trial data with blinded assessment and prospective registration remain limited; this study addresses that gap directly.

Hypotheses

• H0: there is no significant difference between MWM and conventional physiotherapy in SPADI change over 6 weeks.
• H1: the MWM group shows a significantly greater improvement in SPADI over 6 weeks.

Feasibility

• Setting: outpatient physiotherapy department of a teaching hospital, which sees a steady stream of referred frozen-shoulder patients.
• Equipment: mobilisation belts, plinths, universal goniometers, printed SPADI and NPRS forms — all inexpensive and already available.
• Time: synopsis and approvals in months 1–2, recruitment and treatment over months 3–6, analysis and write-up in months 6–8.
• Ethics: IEC approval, CTRI registration, written informed consent, treating therapist separate from assessor, and predefined criteria for withdrawal and referral.

In scope

• Adults aged 40–65 years with idiopathic (primary) adhesive capsulitis in the stiffness phase, unilateral or with one clearly symptomatic side.
• Two treatment groups over a 6-week, thrice-weekly course in one hospital outpatient department.
• SPADI, NPRS and goniometric passive ROM at three time points, measured by a blinded assessor.
• Adherence, adverse events, withdrawal and glycaemic-status records.

Out of scope

• Post-traumatic, post-surgical and long-standing secondary stiffness of more than one year's duration.
• Injection therapy, arthrographic distension, arthroscopic release and other medical or surgical interventions.
• Follow-up beyond the treatment period (a 3-month retention check is noted as future work).
• Bilateral simultaneous cases, which would confound which shoulder is measured.

Study design: prospective, two-arm, parallel-group randomised controlled trial with blinded outcome assessment, reported against the CONSORT checklist.

Setting: outpatient physiotherapy department of a tertiary teaching hospital.

Sample size: computed in G*Power for the comparison of two independent means on SPADI change. For example, if a cited trial or an in-house pilot suggests a between-group difference of 15 SPADI points with SD 18 (d ≈ 0.83), α = 0.05 and 80% power require about 23 per group; allowing ~10% attrition gives 52 participants (26 per group). Replace these illustrative numbers with the values from the study you justify in your review of literature.

Inclusion criteria: age 40–65; clinical diagnosis of primary adhesive capsulitis in the stiffness phase (passive ROM restriction in the capsular pattern, external rotation most limited, symptoms 3–12 months); pain at rest or on movement on the NPRS up to 7; able to give informed consent.

Exclusion criteria: trauma or surgery on the same shoulder; clinical signs of rotator cuff tear or cervical radiculopathy; corticosteroid injection in the past 6 weeks; uncontrolled systemic illness; inflammatory arthropathy; pregnancy; skin lesions or allergy at the treatment site; prior frozen shoulder on the same side.

Randomisation and blinding: computer-generated variable-block randomisation with allocation in sequentially numbered opaque sealed envelopes opened by the treating therapist after baseline testing; the assessor measuring outcomes is different from, and not informed of, the allocation; participants are asked not to discuss the treatment with the assessor.

Interventions (3 sessions/week × 6 weeks):

• MWM group: pain-free sustained glides applied manually with a belt — lateral glide for flexion and abduction, external-rotation glides in available range — 3 sets of 10 repetitions with end-range overpressure, supplemented by a daily home programme of the same pain-free active movements.
• Conventional group: hot pack 10 minutes; Maitland grade III–IV oscillatory glides to the stiff direction (postero-anterior and caudal), 3 sets of 60 seconds; pendular exercises, capsular stretching in flexion, abduction and external rotation, 10 repetitions each; same daily home stretching programme.

Outcome measurement: SPADI (13 items, pain and disability subscales, 0–100) filled in the participant's language with translation checks; NPRS (0–10, current and 24-hour worst); passive ROM with a universal goniometer using a written protocol (supine for flexion and abduction, seated with arm supported for external rotation), same assessor, same time of day, three readings averaged.

Ethics and registration: IEC approval before any screening; CTRI registration before the first enrolment; written informed consent per the ICMR National Ethical Guidelines (2017); coded case-report forms with the master chart kept under the guide's custody; referral pathway for any participant whose condition deteriorates.

Statistical analysis: Shapiro–Wilk for normality; baseline comparisons by independent t-test/chi-square; two-way mixed (group × time) repeated-measures ANOVA on SPADI and ROM with Bonferroni post-hoc; Mann–Whitney U for NPRS if non-normal; intention-to-treat with last-observation carried forward; mean differences with 95% CI; change compared against published MDC/MCID for SPADI; subgroup description by diabetes status; SPSS throughout.

The trial is organised around one eligibility gate, concealed allocation, two matched treatment pathways and a blinded measurement spine. The flowchart below is the study flow used in the dissertation and at the viva; it doubles as the skeleton of the CONSORT diagram.

flowchart TD
  A["Referred shoulder pain patients, orthopaedic OPD"] --> B{"Primary adhesive capsulitis, stiffness phase, 40-65 years?"}
  B -->|No| X["Excluded, reason recorded"]
  B -->|Yes| C["Written informed consent"]
  C --> D["Baseline: SPADI, NPRS, goniometric ROM by blinded assessor"]
  D --> E["Sequentially numbered opaque envelope opened"]
  E --> F["Group A: Mulligan MWM, 3 sessions per week for 6 weeks"]
  E --> G["Group B: hot pack, Maitland glides and stretching, same schedule"]
  F --> H{"Pain-free glide reproduced?"}
  H -->|No| H2["Glide direction and dosage adjusted and logged"]
  H -->|Yes| F2["3 sets of 10 reps with overpressure + home programme"]
  G --> I["Week 3: outcomes + adverse-event review"]
  F2 --> I
  I --> J["Week 6: outcomes by the same blinded assessor"]
  J --> K["Group x time repeated-measures ANOVA vs MDC and MCID"]
  K --> L["CONSORT flow, results, discussion, conclusion"]

Treatment standardisation

Measurement control

• One calibrated goniometer per centre; same positions and landmarks written on the CRF; three readings averaged per motion.
• The assessor records outcomes before the treating therapist is seen, and never opens the allocation envelope.
• SPADI translation into the local language is checked by forward and back translation before use.

• A 3- and 6-month follow-up to test whether MWM's early gains persist after treatment stops.
• A three-arm trial adding exercise-only or corticosteroid-injection-plus-physiotherapy groups to place manual therapy in the real treatment pathway.
• Diabetes-stratified randomisation to test whether glycaemic status modifies the response, given the high Indian prevalence.
• Cost and session-count analysis — if effects are equal, the cheaper and shorter regimen matters for busy OPDs.
• A tele-rehabilitation arm with video-guided home exercises for patients who travel far.