Upper Cross SyndromeNCT06108635
Additional Effects of Maitland Mobilization With Mckenzie Exercises on Kinesiophobia and Range of Motion in Upper Cross Syndrome
A study testing McKenzie Exercises, Maitland mobilization and Heat Therapy in people with Upper Cross Syndrome, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Upper cross syndrome is a postural condition that is characterized by muscle imbalance in neck region. It is described as a pattern of crossed tightness in trapezius, levator scapulae and pectoralis major and minor with crossed weakness in neck flexors,rhomboids,serratus anterior weakness due to poor working habits… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Upper Cross Syndrome
- What is being tested?
- McKenzie Exercises, Maitland mobilization and Heat Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2023to 10 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group:18-45 years with diagnosed upper cross syndrome
- Both males and females
- Neck pain with a score between 4-8 in NPRS
- Able to provide informed consent and understand therapists instruction
Who cannot join
- History of Cervical or upper limb fracture
- Vertibrobasilar insufficiency
- Cervical spine surgery
- Spinal infections and tumors
- Osteoporosis
- Metabolic disorders
- Rheumatiod Arthritis
- Inflammatory Arthritis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Marwa Asim, DPT,OMPT, 03335339457, marwa@fui.edu.pk
About this study
Upper cross syndrome is a postural condition that is characterized by muscle imbalance in neck region. It is described as a pattern of crossed tightness in trapezius, levator scapulae and pectoralis major and minor with crossed weakness in neck flexors,rhomboids,serratus anterior weakness due to poor working habits and inappropriate ergonomics. It has multiple treatment options and manual therapy is on of them. Maitland mobilizations are widely used for upper cross syndrome. However limited literature is available on the additional effects of Maitland mobilizations with Mckenzie exercises in upper cross syndrome.
Read the detailed description
Upper cross syndrome is a postural condition that is experinced by 32.43% in desk workers. It is one of the most prevelant leading cause of neck pain and musculoskeletal conditions that has a major impact on a person life by effecting activities of daily living.Neck pain ranked 21st among Global burden of diseses and fourth highest overall for all disabilities. Prevelance of neck pain in Pakistan is 62%. Neck pain has a strong positive correlation with kinesiophobia. Kinesiophobia is a strong predictor of pain intensity,proprioception and functional performance. Patients with upper cross syndrome presents with forward head posture, protracted and elongated shoulders,khyphosis of thoracic spine,winging of scapula and decreased thoracic spine mobility. Upper cross syndrome occurs due to poor faulty posture, extensive use of mobile,laptops,watching T.V,driving and all the other activities that encourages this postural stance.
This study will be a Randomized Control Trial conducted in rehab opd of Fauji Foundation hospital. Both genders with age 18-45 years who had diagnosed with upper cross syndrome will be recruited into two groups using non probability purposive sampling technique. Sample size has been calculated by using open epi sample calculator and it is calculated to be 28. Patients with primary neck pain complain referred to rehab opd of FFH and local physiotherapy clinics of Rawalpindi/Islamabad will be recruited according to the eligibility criteria. Participants will be briefed regarding study objectives, study procedures, risks and benefits of treatment, voluntarily participation and right to withdraw. After taking informed consent,basic demographics, baseline assessment, participants will be randomly allocated into the two groups using sealed enveloped method. Group A(controlled group) will be recieving moist heat therapy(15 minutes hot pack) and Mckenzie exercise(5 reps x 2 sets in week 1 then progressed to 10 reps x 3 sets in week 2) . While group B will be given Maitland mobilization (Central glidewith grade i and ii mobilizations in week 1 and then progressed to grade iii and iv in week 2) with Mckenzie exercises along with moist heat therapy. Before and after the intoduction of intervention kinesiophobia,range of motion and pain will be assessed before and after the treatment.Frequency: thrice biweekly for 2 weeks for a total of 6 treatment sessions.
- Conditions
- Upper Cross Syndrome
- Being tested
- McKenzie Exercises, Maitland mobilization, Heat Therapy
- Medical subject headings
- Oculocerebral hypopigmentation syndrome type Preus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McKenzie ExercisesProcedure or surgery
These can be performed in sitting and the protocol includes,
- Retraction and extension
- Retraction and extension with rotation
- Postural correction
There will be 2 sets of 5 repetitions in week 1 and 3 sets of 10 repetitions in week 2 followed by alternative days in a week. Each set is 30 seconds and each repetition is given in 2 seconds.
Maitland mobilizationProcedure or surgery
The grade I and II Maitland mobilizations are given in week 1 and then progressed to grade III and IV in week 2
Heat TherapyProcedure or surgery
Moist heat therapy with hot pack.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | McKenzie exercises with moist heat therapy will be given as intervention to experimental group. 2 sets of 5 reps will be given then progressed to 3 sets of 10 repetitions .Participants will be given Hot pack for 15 minutes. Receives: Procedure: McKenzie Exercises; Procedure: Heat Therapy |
| Group B | Experimental | The patients will be given Maitland mobilization (central glide on effected cervical spinous process) with McKenzie exercises. Grade i and ii mobilizations will be given in week 1 and then progressed to grade iii and iv in week 2. The total time duration will be 25-30 minutes. Participants will be given Hot pack for 15 minutes. Receives: Procedure: McKenzie Exercises; Procedure: Maitland mobilization; Procedure: Heat Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia
It will be defined as an excessive irrational and debilitating fear of movement and is associated with a feeling of vulnerability to injury in response to movement and includes more than 20 score on Tampa scale of kinesiophobia.
Measured: 2 weeks
Range of motion
It is composed of three inclinometers in frontal, sagittal and horizontal position. Each compass of the inclinometer is placed on the zero degree and measures the range of motion.
Measured: 2 weeks
Secondary outcomes (1)
Severity of neck pain
Numeric pain rating scale. Greater score means greater severity.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start15 Feb 2023
- Primary completion20 Nov 2023 (estimated)
- Study completion10 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Cross SyndromeStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Group Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108635
- Sponsor's protocol ID
- FUI/CTR/2023/19
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Maitland Mobilization With Mckenzie Exercises on Kinesiophobia and Range of Motion in Upper Cross Syndrome
- ClinicalTrials.gov ID
- NCT06108635
- Acronym / sponsor ID
- FUI/CTR/2023/19
- Conditions
- Upper Cross Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 20 Nov 2023 (estimated)
- Study completion
- 10 Feb 2024 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Upper cross syndrome is a postural condition that is characterized by muscle imbalance in neck region. It is described as a pattern of crossed tightness in trapezius, levator scapulae and pectoralis major and minor with crossed weakness in neck flexors,rhomboids,serratus anterior weakness due to poor working habits and inappropriate ergonomics. It has multiple treatment options and manual therapy is on of them. Maitland mobilizations are widely used for upper cross syndrome. However limited literature is available on the additional effects of Maitland mobilizations with Mckenzie exercises in upper cross syndrome.
Detailed description
Upper cross syndrome is a postural condition that is experinced by 32.43% in desk workers. It is one of the most prevelant leading cause of neck pain and musculoskeletal conditions that has a major impact on a person life by effecting activities of daily living.Neck pain ranked 21st among Global burden of diseses and fourth highest overall for all disabilities. Prevelance of neck pain in Pakistan is 62%. Neck pain has a strong positive correlation with kinesiophobia. Kinesiophobia is a strong predictor of pain intensity,proprioception and functional performance. Patients with upper cross syndrome presents with forward head posture, protracted and elongated shoulders,khyphosis of thoracic spine,winging of scapula and decreased thoracic spine mobility. Upper cross syndrome occurs due to poor faulty posture, extensive use of mobile,laptops,watching T.V,driving and all the other activities that encourages this postural stance.
This study will be a Randomized Control Trial conducted in rehab opd of Fauji Foundation hospital. Both genders with age 18-45 years who had diagnosed with upper cross syndrome will be recruited into two groups using non probability purposive sampling technique. Sample size has been calculated by using open epi sample calculator and it is calculated to be 28. Patients with primary neck pain complain referred to rehab opd of FFH and local physiotherapy clinics of Rawalpindi/Islamabad will be recruited according to the eligibility criteria. Participants will be briefed regarding study objectives, study procedures, risks and benefits of treatment, voluntarily participation and right to withdraw. After taking informed consent,basic demographics, baseline assessment, participants will be randomly allocated into the two groups using sealed enveloped method. Group A(controlled group) will be recieving moist heat therapy(15 minutes hot pack) and Mckenzie exercise(5 reps x 2 sets in week 1 then progressed to 10 reps x 3 sets in week 2) . While group B will be given Maitland mobilization (Central glidewith grade i and ii mobilizations in week 1 and then progressed to grade iii and iv in week 2) with Mckenzie exercises along with moist heat therapy. Before and after the intoduction of intervention kinesiophobia,range of motion and pain will be assessed before and after the treatment.Frequency: thrice biweekly for 2 weeks for a total of 6 treatment sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Group Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: McKenzie Exercises, Procedure: Heat TherapyMcKenzie exercises with moist heat therapy will be given as intervention to experimental group. 2 sets of 5 reps will be given then progressed to 3 sets of 10 repetitions .Participants will be given Hot pack for 15 minutes. |
| Group B | Experimental | Procedure: McKenzie Exercises, Procedure: Maitland mobilization, Procedure: Heat TherapyThe patients will be given Maitland mobilization (central glide on effected cervical spinous process) with McKenzie exercises. Grade i and ii mobilizations will be given in week 1 and then progressed to grade iii and iv in week 2. The total time duration will be 25-30 minutes. Participants will be given Hot pack for 15 minutes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age group:18-45 years with diagnosed upper cross syndrome
- Both males and females
- Neck pain with a score between 4-8 in NPRS
- Able to provide informed consent and understand therapists instruction
Key exclusion criteria (8 listed)
- History of Cervical or upper limb fracture
- Vertibrobasilar insufficiency
- Cervical spine surgery
- Spinal infections and tumors
- Osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| McKenzie ExercisesThese can be performed in sitting and the protocol includes, 1. Retraction and extension 2. Retraction and extension with rotation 3. Postural correction There will be 2 sets of 5 repetitions in week 1 and 3 sets of 10 repetitions in week 2 followed by alternative days in a week. Each set is 30 seconds and each repetition is given in 2 seconds. | Procedure or surgery | Group A, Group B |
| Maitland mobilizationThe grade I and II Maitland mobilizations are given in week 1 and then progressed to grade III and IV in week 2 | Procedure or surgery | Group B |
| Heat TherapyMoist heat therapy with hot pack. | Procedure or surgery | Group A, Group B |
Primary outcome
Kinesiophobia
Time frame: 2 weeks
It will be defined as an excessive irrational and debilitating fear of movement and is associated with a feeling of vulnerability to injury in response to movement and includes more than 20 score on Tampa scale of kinesiophobia.
Range of motion
Time frame: 2 weeks
It is composed of three inclinometers in frontal, sagittal and horizontal position. Each compass of the inclinometer is placed on the zero degree and measures the range of motion.
1 secondary outcome
Severity of neck pain
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McKenzie Exercises, Maitland mobilization and Heat Therapy in people with Upper Cross Syndrome, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hira Nawaz, DPT,MS-MSKPT (03165311943, hiranawaz09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.