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Study on Frozen Shoulder: Evaluating the Effectiveness of Physiotherapy, Triamcinolone Acetonide, and Lidocaine in Improving Shoulder Function and Reducing Pain

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on a condition known as frozen shoulder, which causes pain and stiffness in the shoulder joint. The study aims to explore the effectiveness of different treatments to improve shoulder function and reduce pain. The treatments being studied include physiotherapy, which involves exercises and physical methods to improve movement, and intra-articular corticosteroid injections, which are injections given directly into the joint to reduce inflammation and pain. The corticosteroid used in this study is triamcinolone acetonide, a type of medication that helps reduce swelling and pain. Additionally, a combination of physiotherapy and corticosteroid injections will be evaluated.

Another treatment being tested involves a mixture of cetrimide and lidocaine. Cetrimide is an antiseptic, and lidocaine is a local anesthetic that numbs the area to relieve pain. These treatments are administered through an injection directly into the shoulder joint. The purpose of the study is to compare how well these treatments work individually and in combination over a period of three months.

Participants in the study will receive one of the treatments and will be monitored for changes in shoulder pain and function. The study will assess improvements using various measures, including the Shoulder Pain and Disability Index, which evaluates the impact of shoulder pain on daily activities. The goal is to determine which treatment or combination of treatments provides the best relief for individuals with frozen shoulder.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to evaluate your shoulder condition. This includes measuring the range of motion and assessing pain levels using a scale from 0 (no pain) to 10 (worst possible pain).

  2. Step 2

    Treatment allocation

    You will be assigned to one of the treatment groups. The treatments being compared are physiotherapy, corticosteroid injections, and a combination of both. The goal is to determine which treatment is most effective for improving shoulder function and reducing pain.

  3. Step 3

    Corticosteroid injection

    If you are in a group receiving corticosteroid injections, you will receive an intra-articular injection of triamcinolone acetonide and lidocaine directly into the shoulder joint. This is intended to reduce inflammation and pain.

  4. Step 4

    Physiotherapy sessions

    If you are in a group receiving physiotherapy, you will attend regular sessions with a physiotherapist. These sessions will focus on exercises to improve shoulder movement and reduce pain.

  5. Step 5

    Combination treatment

    If you are in the combination treatment group, you will receive both the corticosteroid injection and physiotherapy sessions. This approach aims to maximize the potential benefits of both treatments.

  6. Step 6

    Follow-up assessments

    Throughout the study, follow-up assessments will be conducted to monitor your progress. These assessments will measure pain levels, shoulder function, and overall well-being using various questionnaires and scales.

  7. Step 7

    Final evaluation

    At the end of the study period, a final evaluation will be conducted to assess the overall effectiveness of the treatment you received. This will include a comprehensive review of your shoulder function and pain levels.

Who can join the trial?

5 criteria

  • Have had shoulder pain for less than 9 months.
  • Have a reduced passive range of movement in the shoulder joint compared to the other shoulder. This means you cannot move your shoulder as much as the other one, with a difference of more than 30 degrees in at least two of these movements: moving your arm forward, lifting it to the side, or rotating it outward.
  • Experience shoulder pain with an intensity greater than 3 on a scale from 0 (no pain) to 10 (worst possible pain) during activity or rest, including at night.
  • Be between the ages of 18 and 70 years old.
  • Be capable of giving signed informed consent, which means you understand the study and agree to follow its requirements and restrictions.

Who cannot join the trial?

3 criteria

  • Patients who do not have a diagnosis of frozen shoulder cannot participate. A frozen shoulder is a condition that causes pain and stiffness in the shoulder.
  • Patients who are not within the age range of 18 to 65 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot give consent for themselves, cannot participate.
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Investigated drugs

  • Corticosteroid Injections

    are a type of medication used to reduce inflammation and relieve pain in the shoulder. In this trial, they are injected directly into the shoulder joint to help improve movement and decrease discomfort for patients with frozen shoulder. The goal is to see if these injections can help improve shoulder function when used alone or in combination with physical therapy.

  • Physical Therapy

    is a treatment that involves exercises and movements designed to improve the function and mobility of the shoulder. In this trial, physical therapy aims to help patients with frozen shoulder regain their range of motion and reduce pain. The study is looking at how effective physical therapy is on its own and when combined with corticosteroid injections.

What is already known about the treatment

Corticosteroid Injections – Corticosteroid injections are administered directly into the shoulder joint to help reduce inflammation and pain associated with frozen shoulder. Currently, these injections are widely used in medicine and are well-documented in medical literature for their effectiveness in managing joint pain and inflammation. The main therapeutic indication for corticosteroid injections in this context is to improve shoulder function and reduce pain in patients with frozen shoulder. At the molecular level, corticosteroids work by suppressing the immune response and decreasing the production of substances that trigger inflammation. They are classified pharmacologically as anti-inflammatory agents.

Investigated diseases

Frozen Shoulder – Frozen shoulder, also known as adhesive capsulitis, is a condition characterized by stiffness and pain in the shoulder joint. It typically progresses through three stages: the freezing stage, the frozen stage, and the thawing stage. During the freezing stage, pain gradually increases, and shoulder movement becomes limited. In the frozen stage, pain may decrease, but the shoulder remains stiff, significantly restricting movement. The thawing stage involves a gradual return of shoulder movement and a decrease in stiffness. The entire process can take several months to years to resolve completely.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519728-26-00Estimated enrolment180 patientsSponsorOslo University Hospital HF

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