The Effect of Manipulation Under Anesthesia for Secondary Frozen Shoulder: A Randomized Controlled Trial

Study Design

This trial is a prospective, single-center randomized controlled trial conducted in accordance with the principles of the Declaration of Helsinki. The data reported from this trial comply with the Consolidated Standards of Reporting Trials (CONSORT) statement. The study was conducted in the local hospital and was approved by the local ethics committee board (Shuguang Hospital, ChiECRCT20200121). An informed consent form was signed by all participants prior to study. The clinical trial was registered in the Chinese Clinical Trial Registry (ChiCTR2200060269).

Randomization and Blinding

The CONSORT diagram for participants is shown in Fig. 1. Patients were randomly assigned to one of the two following groups by one researcher independently: an MUA plus EX group or a CLX plus EX group. Randomization was done by using a computer program that included a randomized table of numbers, which was created by an independent individual who was not involved in the recruitment and treatment of patients. Numbered cards with a random assignment and containing information about the group allocation in opaque, sealed envelopes were prepared by the independent individual. All participants were blinded to their treatment assignment.

Fig. 1figure 1

Consolidated Standards of Reporting Trials (CONSORT) flow diagram. MUA manipulation under anesthesia, CLX celecoxib, EX exercise

Sample Size Calculation

Power analysis was conducted before the commencement of patient recruitment. Constant–Murley Score (CMS) is the primary outcome parameter. Based on the ability to confirm a difference between treatment groups of at least 10 points of CMS, the reported minimum clinically important difference (MCID) of CMS is 10 points [23]. According to previous research, the study shows an estimated mean CMS of 71 and a standard deviation of 15.5 points [24]. On the basis of these parameters, to achieve 90% power at a two-sided 5% significance, 65 patients were required in each group with a 20% dropout rate. We rounded up it to 68.

Participants

The patients were recruited from outpatients and inpatients of the orthopedics and traumatology department. Patients who were willing to participate in the research were evaluated to decide whether their condition met the study aim. In order to be eligible to participate in this study, patients must meet all of the inclusion criteria and none of the exclusion criteria.

Inclusion criteria were as follows: (1) subjects aged 40–70 years; (2) subjects clinically diagnosed with secondary FS characterized by restriction of function in the affected shoulder; (3) subjects that have definite cause, including trauma, non-osteoporotic fractures around the shoulder, long-term immobilization after lung cancer, breast cancer, or other surgery; (4) subjects that have the ability to comprehend the instructions in the study.

Exclusion criteria were as follows: (1) definitive evidence of rotator cuff tear, fracture, tumor in the shoulder, ligament rupture proved by magnetic resonance imaging (MRI); (2) allergy to narcotic drugs; (3) shoulder symptom resulting from skin contracture caused by cervical radiculopathy, brachial plexus lesion, connective tissue disorders, and scald around the shoulder; (4) other known shoulder pathology such as infection and broken skin; (5) pregnant, lactating women; (6) systemic inflammatory joint disease; (7) inability to give informed consent and fill out questionnaires; (8) unwilling to complete the medical observation.

From June 2019 to December 2020, a total of 136 eligible patients with a diagnosis of secondary FS were enrolled in the trial. The 136 patients were randomized to the MUA followed by EX group (n = 68) and celecoxib followed by EX group (n = 68) (Fig. 1).

InterventionAnesthesia

The patient was place in a supine position, with head tilting to the healthy side. A soft thin pillow was placed under the neck and shoulder to expose the puncture site. An interscalene block was performed by the anesthesiologist using ultrasound guidance in the operating room. The interscalene block was located at the space between sternocleidomastoid muscle and anterior scalene muscle. A mixture containing 10 mL 75 mg ropivacaine and 10 mL 2% lidocaine was used for brachial plexus block anesthesia.

MUA

The surgeon stands on the affected side of the patient in a supine position. Under anesthesia, the affected arm was held in anteflexion. The shoulder was gently moved in 180° anteflexion. During the process, we hold the elbow of the affected arm with one hand and the other hand is placed on the proximal humerus near the humeral head at the patient’s axilla to prevent shoulder dislocation. This process is performed three times; these maneuvers result in tearing of fibrosed capsule and ligament, which can often be felt or heard. Next, the shoulder is positioned at external rotation, abduction, and flexion to 180°. Forward flexion to 90° for the shoulder and elbow, the shoulder adducted to 45°. At the end, supine position remained, the affected shoulder abducted to 45°, and rotator interval was conducted. Supine with shoulder internal rotation, the thumb can touch the healthy-side shoulder blade at least.

Control Group

Eligible participants randomized to the placebo group received 200 mg celecoxib (Celebrex, Pfizer) every day for 12 days.

Exercises 1.

Climbing wall training.

The patient stood facing the wall with feet shoulder-width apart. The toes approach the edge of wall. Five splayed fingers are placed on the wall, climbing high slowly along the wall within the patient’s pain tolerance. If necessary, the process was finished with the aid of the heathy upper limb or others.

2.

Putting on the other shoulder training.

The affected-side elbow remained in flexion and close to the chest within pain limitation. The healthy-side hand was placed behind the affected elbow. The affected elbow was pushed up gradually so the affected-side hand reaches the other shoulder.

3.

Pulling hand back.

Patients kept the position of sitting or upright. The affected upper limb was placed behind the back, adducted and raised gradually. Another healthy hand was used to help the affected hand raise to the highest position.

Note: repeat the three steps three times a day, three times each time.

Outcomes and Follow-up

An independent physician who was blinded to the intervention collected all the data at 0 week (baseline), 1 day, 2 weeks, 4 weeks, and 12 weeks after treatment. The primary outcome was CMS. Secondary outcomes included the McGill Pain Questionnaire (MPQ) containing Pain Rating Index (PRI) and Present Pain Intensity (PPI) and passive ROM, including forward flexion, abduction, internal rotation, and external rotation with the arm at the side.

The passive flexion, passive abduction, and passive external rotation were measured using a digital angle ruler. The smallest unit of measurement is 5°. The passive internal rotation was expressed as the highest spinous process level at the back reached with the tip of the thumb. The vertebra level of sacrum was recorded as 1 point. From the fifth to first lumbar vertebra, it was numbered serially 2–6, and so on.

Statistical Analysis

R 4.0.3 statistical software was used for all statistical analysis. A P value less than 0.05 was considered statistically significant. The continuous data are expressed as mean and standard deviation (SD), and the categorical data are expressed as frequency and percentages. The chi-square test was used to detect differences between binary variables. The Kolmogorov–Smirnov test was applied to the continuous data to determine if they followed a normal distribution. Baseline demographic characteristics and the mean improvement from baseline in each clinical outcome at each follow-up visit were assessed for each patient. Student t test (for continuous data that were normally distributed), the Mann–Whitney U test (for continuous data that were not normally distributed), or generalized linear mixed model (GLMM) were applied for the study comparison. For outcomes analysis, GLMM was used for repeated measures. The changes from baseline measurements were modeled with GLMM. Differences in mean changes from baseline for each outcome at each time were compared between groups. The outcome model included fixed effects for treatment, time, and the interaction of trial group with time.

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