NCT06613594

Brief Summary

Frozen shoulder is a common musculoskeletal condition. Painful gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.Range of motions and capsular pattern affected in frozen shoulder. Physiotherapists have a wide range of options in managing frozen shoulder including Electrotherapeutic modalities, kaltenborn mobilization, Maitland's mobilization,Mulligan's mobilization and Manipulation. So far studies have shown the efficacy of different treatments in combination or in isolation.some studies on Kaltenborn mobilization , but no obseved comparative effects of Kaltenborn mobilization i.e translatoric glides and traction mobilzation in patients with frozen shoulder.In clinically both techniques of kaltenborn are used but there is no evidence regarding which one is more effective. .If found effective,this study can help to use best clinical treatment in the managemnent of frozen shoulder.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

September 26, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

September 23, 2024

Last Update Submit

September 23, 2024

Conditions

Keywords

chronic pain, kaltenborn traction, kaltenborn linear translatoric glides

Outcome Measures

Primary Outcomes (2)

  • Fear Avoidance belief

    fear of pain to do movement will be assessed by using fear avoidance belief questionnaire .

    2 weeks

  • Pain Intensity

    Pain will be assessed using Visual Analog scale which is 0-100 item scale.

    2 weeks

Secondary Outcomes (2)

  • Shoulder Range of motion

    2 weeks

  • Shoulder Disability

    2 weeks

Study Arms (3)

Conventional Physical Therapy Group

ACTIVE COMPARATOR

Patients in this group will recieve conventional physical therapy including Hot pack and Tens for 10 to 15 minutes.Broomstick ROM exercises such as Internal \& external rotation,Extension,flexion,abduction,these are Low intensity, short duration, 1-5 sec, 2-3 times/day, pain free passive, 3 sets of 10 reps with 1 minute rest in between will be given, Codman circular motion exercises(1time clockwise ,1 time anticlcock wise) 2-3 times/day with 10reps .Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall.Every session will be given for 30 minutes and a total of 10 sessions would be conducted over a period of 2 weeks.

Other: Conventional physical therapy

Conventional physical therapy+kaltenborn traction Group

EXPERIMENTAL

Patients will recieve kaltenborn traction mobiliztion in addition to conventional physical therapy including Hot pack and tens for 10 to 15 minutes , Broomstick ROM exercises such as Flexion, Internal \& external rotation,Extension, Abduction,these are Low intensity, short duration, 1-5 sec, 2-3 times/day with 10 reps, pain free passive, AAROM.Codman circular motion exercises (1time clockwise ,1 time anticlockwise) 2-3 times/day with 10 reps. kaltenborn direction non specific traction mobilization for (1 minute), 3 sets of 10 reps with 1 minute rest in between will be given. Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall.Every session will be given for 30 minutes and a total of 10 sessions would be conducted over a period of 2 consecutive weeks.

Other: Conventional physical therapyOther: Kaltenborn traction mobilization

Conventional physical therapy+kaltenborn translatoric glides Group

EXPERIMENTAL

Patient will recieve kaltnborn linear translatoric glides in addittion to Conventional physical therpay including Hot packs and tens for 10-15 minutes. Broomstick ROM exercises such as flexion,Exention,Internal rotation,External roation and Abuction,these are low intensity,short duration,1- 5sec,2-3 times/ day with10 reps,pain free passive, AAROM.Codman exercises circular motion exercises (1time clock wise ,1Time anticlockwise), 2-3 times/day with 10reps. Kaltenborn direction specific linear tranlatoric glides, rhtymic 5reps of each glide,such anterior glide for extension and external rotation,caudal glide for abduction,post glide for flexion and internal roation,these3 sets of painless glides will perfromed with 10 reps,rest of 1 minutes between these sets. Strengthening exercises including Isometric in all planes,5sec hold,1 sets of 10 each direction against wall. Every session will be given for 30 minutes and a total of 10 session would be conduted over a period of 2 weeks.

Other: Conventional physical therapyOther: Kaltenborn translatoric glides

Interventions

Patients will receive hot pack, Broom stick ROM exercises, Codman and strengthening exercises. A total of 10 sessions, 5 sessions per week for 2 consecutive weeks.

Conventional Physical Therapy GroupConventional physical therapy+kaltenborn traction GroupConventional physical therapy+kaltenborn translatoric glides Group

kaltenborn direction non specific traction mobilization for (1 minute), 3 sets of 10 reps with 1 minute rest in between will be given.

Conventional physical therapy+kaltenborn traction Group

Kaltenborn direction specific linear tranlatoric glides, rhtymic 5reps of each glide, such anterior glide for extension and external rotation, caudal glide for abduction,post glide for flexion and internal roation,these3 sets of painless glides will performed with 10 reps,rest of 1 minutes between these sets.

Conventional physical therapy+kaltenborn translatoric glides Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with Nonspecific frozen shoulder without specific identifiable etiology (i.e. infection, inflammatory disease)
  • years of age both males and females.
  • Chronic shoulder pain \> 3 months.
  • Positive capsular pattern.

You may not qualify if:

  • Patients with other shoulder joint pathologies, such as fractures or dislocations, glenohumeral instability or rotator cuff pathologies in the affected shoulder.
  • Subjects who have undergone surgery or have experienced an acute trauma to the shoulder.
  • Individuals with current or history of neurological disorders (such as stroke, Alzheimer's, or Parkinson's), rheumatologic diseases (such as rheumatoid arthritis or systemic lupus erythematous), or systemic illnesses (such as thyroid disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

BursitisChronic Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Afifa Zuha, MS-MSKPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial having three groups. One group will receive conventional physical therapy, the second will receive conventional physical therapy along with kaltenborn linear translatoric glides and third group recevied conventional therapy along with kaltenborn traction mobilization. All groups will be recruited concurrently.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 26, 2024

Study Start

August 20, 2024

Primary Completion

December 1, 2024

Study Completion

December 15, 2024

Last Updated

September 26, 2024

Record last verified: 2024-08

Locations